869 Lims Jobs - Page 29

About Sun Pharma: Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of US$ 5.4 billion. Supported by 43 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Job Summary sLIMS Implementation Specialist will be responsible for the successful deployment, configuration, and ongoing support of our Laboratory Information Management System (SLIMS). This role requires a deep understanding of laboratory workflows, strong technical skills, and the ability to work closely with cross-functional teams to ensure the SLIMS meets the needs of the organization. Roles and Responsibilities • Support in implementation and configuration of the sLIMS, ensuring alignment with laboratory workflows and regulatory requirements. • Execute the tasks defined in project plans, adhering to timelines, for successful implementation of sLIMS. • Configure sLIMS software to meet the specific needs of the laboratory, configuring workflows, and setting up user roles and permissions. • Provide training and support to end-users, ensuring they are proficient in using the sLIMS. • Troubleshoot and resolve any issues related to sLIMS performance, functionality, and integration with other systems/instruments. • Maintain comprehensive documentation of the sLIMS implementation process, including user guides and technical manuals. • Shall be aware about documentation of sLIMS application as per GMP. Shall be able to create and manage documentation of sLIMS application to ensure system is in compliance state. Qualifications and Preferences Qualifications: • Bachelor's degree in Information Technology, or Computer Science or related field. • Minimum of 4-5 years of experience in sLIMS implementation, preferably in a pharmaceutical or biotech environment. • Strong understanding of laboratory processes and workflows. • Proficiency in sLIMS software (Expertise on CaliberLIMS is preferred) • Ability to manage multiple tasks simultaneously. • Strong analytical and problem-solving skills. • Excellent communication and interpersonal skills. • Experience with regulatory compliance requirements (e.g., FDA, GMP, GLP). Preferred Qualifications: • Advanced degree in Life Sciences, Information Technology, or a related field. • Familiarity with laboratory instruments and their integration with SLIMS • Experience with Caliber LIMS is preferred. • Good documentation skills to create and manage GxP documents. Selection Process: Interested Candidates are mandatorily required to apply through the listing on Jigya. Only applications received through Jigya will be evaluated further. Shortlisted candidates may need to appear in an Online Assessment and/or a Technical Screening interview administered by Jigya, on behalf on Sun Pharma Candidates selected after the screening rounds will be processed further by Sun Pharma Show more Show less

Overview: Jhpiego is a non-profit global health leader and Johns Hopkins University affiliate that is saving lives, improving health and transforming futures. We partner with governments, health experts and local communities to build the skills and systems that guarantee a healthier future for women and families. Through our partnerships, we are revolutionizing health care for the world’s most disadvantaged and vulnerable people. In India, Jhpiego works across various states in close collaboration with national and state governments, providing technical assistance in the areas of family planning, maternal and child health, strengthening human resources for health, and non-communicable diseases. These programs are funded by USAID, Bill & Melinda Gates Foundation, David & Lucile Packard Foundation, Children’s Investment Fund Foundation (CIFF), MSD for Mothers and other anonymous donors Jhpiego intends to respond to the urgency and magnitude of the second wave of COVID-19 in India while identifying areas and modalities of implementation aligning it to the country and state’s response to the surge. Jhpiego is hiring for the position of National Program Officer – Laboratory Systems based at New Delhi for its RISE project. The position will work closely with the India country office and state office teams for strengthening of lab capacity. The position will report to the Associate Director. Responsibilities: Lead national-level planning, budgeting, and project management for laboratory systems strengthening under the RISE project. Develop—and continuously refine—national strategies and roadmaps for laboratory capacity enhancement, aligning with government priorities. Serve as the principal liaison for laboratory systems between Jhpiego, the Ministry of Health & Family Welfare, Department of Animal Husbandry and Dairying, state health departments, and other stakeholders, fostering collaboration and ensuring alignment of objectives. Implement comprehensive gap assessments of laboratory infrastructure, workflows, biosafety, and biosecurity systems; drive targeted improvements through infrastructure upgrades, equipment deployment, and optimized SOPs. Champion the introduction and scale-up of advanced diagnostic modalities, including metagenomic (NGS) and other molecular techniques, to enhance pathogen identification and genomic surveillance. Establish a rigorous quality management system—encompassing proficiency testing, audits, and corrective action plans—to sustain high standards in diagnostic accuracy and biosafety compliance. Design and lead national-level training programs for laboratory personnel on pathogen-specific diagnostics, data management, biosafety, and laboratory leadership skills. Mentor state-level laboratory teams and focal points, building their capacity to manage laboratories independently and to train others. Document and disseminate best practices, guidelines, and policy briefs on laboratory strengthening, facilitating knowledge exchange among government partners and technical stakeholders. Architect and oversee the roll-out of a robust national laboratory network, including sample referral pathways and electronic data management platforms that support real-time reporting and analysis. Collaborate with digital health teams to optimize laboratory information management systems (LIMS) integration with national health surveillance databases. Analyze laboratory performance metrics and surveillance data to inform strategic decision-making and to produce high-quality reports for donors and government counterparts. Cultivate and manage strategic partnerships with international agencies, NGOs, academic institutions, and private sector stakeholders to leverage resources and technical expertise. Represent Jhpiego at national and international forums, advocating for investments in laboratory systems and shaping policy dialogues around diagnostic preparedness. Identify and pursue new funding opportunities, contributing to proposal development and budget design. Required Qualifications: Abilities/Skills: Familiarity with Biosafety norms, Quality management systems and laboratory information management systems Ability to work independently and as part of a team in a fast-paced environment. Experience working with government agencies, international organizations, and NGOs. Ability to analyse data and produce documents and reports of professional quality and coordinate activities independently. Fluency in spoken and written English and Hindi required. Computer skills demonstrating competency in MS Office Suite Ability to handle a variety of assignments under pressure of deadlines Ability to multitask and work in a multi-cultural team. Ability to develop productive working relationships with other team members, agencies, stakeholders and other organizations. Excellent communication, interpersonal, and organizational skills. Ability to travel up to 30% of the time. Qualifications/Knowledge and Experience: MD/PhD in microbiology/pathology. At least 7 years’ experience in implementing Lab programs Experience in HIV/TB/PM ABHIM is desirable Experience with next-generation sequencing/metagenomics applications in pathogen surveillance is desirable. Experience in capacity building e.g. developing content, planning, and facilitating training and providing technical assistance. Familiarity with the Indian public health system, newer initiatives in health sector and relevant government policies/ strategies particularly National Health Mission, and Ayushman Bharat. Jhpiego is an equal opportunity employer and offers highly dynamic and enabling work environment. Jhpiego offers competitive salaries and a comprehensive employee benefits package. Women candidates are encouraged to apply. Due to high volume of applications, only shortlisted applicants will receive a response from Jhpiego HR. RECRUITMENT SCAMS & FRAUD WARNING Jhpiego has become aware of scams involving false job offers. Please be advised: Recruiters will never ask for a fee during any stage of the recruitment process. All active jobs are advertised directly on our careers page. Official Jhpiego emails will always arrive from a @Jhpiego.org email address. Please report any suspicious communications to Info@jhpiego.org

Job Category: Quality Job Family: Plant Quality Assurance Job Description: What you’ll do: Support for implementation of LIMS across all labs in Baramati Updation of all RM/PM/FG specs in Oracle Generation of Specifications from Oracle Help the team to implement the entries for all RM/PM/FG data as per spec in Oracle / LIMS Generation of COA from Oracle Updation of complaints in EQMS and use of powder BI for data analysis of complaints Updation of all external / customer audit reports in EQMS QA Data Analysis for Physical, chemical and micro parameters and identify the root cause for all OOS/OOT and document the same. Automation of reports using RPA & Power BI. Develop the protocols for FTR/FRQ and calculation for the same. Standardization of process for calculating the same and the reasons for OOS Play the role of a QA Data Analyst by developing the required tools in RPA / Power BI Main plant Powders – sanitation What You Need To Succeed Qualification: B. Sc (Chemistry)/ Biotechnology Experience: 4 to 8 Years Good knowledge on GMP. Ready to work in rotating (all) shifts Show more Show less

Job title: R&D Data Steward Location: Hyderabad About The Job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients’ daily life, wherever they live and enabling them to enjoy a healthier life. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The R&D Data Office serves as a cornerstone to this effort. Our team is responsible for cross-R&D data strategy, governance, and management. We sit in partnership with Business and Digital, and drive data needs across priority and transformative initiatives across R&D. Team members serve as advisors, leaders, and educators to colleagues and data professionals across the R&D value chain. As an integral team member, you will be responsible for defining how R&D's structured, semi-structured and unstructured data will be stored, consumed, integrated / shared and reported by different end users such as scientists, clinicians, and more. You will also be pivotal in the development of sustainable mechanisms for ensuring data are FAIR (findable, accessible, interoperable, and reusable). Position Summary The R&D Data Steward plays a critical role in the intersection between business and data, where stewards will guide business teams on how to unlock value from data. This role will drive definition and documentation of R&D data standards in line with enterprise. Data stewards will place heavily cross-functional roles and must be comfortable with R&D data domains, data policies, and data cataloguing. Main Responsibilities Work in collaboration with R&D Data Office leadership (including the Data Capability and Strategy Leads), business, R&D Digital subject matter experts and other partners to: Understand the data-related needs for various cross-R&D capabilities (E.g., data catalog, master data management etc) and associated initiatives Document data governance policies, standards and procedures for R&D data Maintain documentation and act as an expert on data definitions, data flows, legacy data structures, access rights models, etc. for assigned domain Document R&D level standards on the nomenclature, content, and structure of information (structured and unstructured data) and metadata, glossaries, taxonomies Manage and maintain quality and integrity of data via data enrichment activities (E.g., cleansing, validating, enhancing etc) Understand and adopt data management tools such as R&D data catalogue, etc Develop effective data sharing artifacts for appropriate usage of data across R&D data domains Ensure the seamless running of the data-related activities and verify data standard application from ingest through access Oversee data pipeline and availability and escalate issues where they surface; ensure on-schedule/on-time delivery and proactive management of risks/issues Work with R&D teams on standards and information management principles, methodologies, best practices, etc. Deliverables Follows defined processes to embed data cleaning, quality, and communication metrics into the CMC – Chemical, Manufacturing & Control – business domain Maintains valid value lists (vocabularies) on reference tables for the CMC – Chemical, Manufacturing & Control – data domain Supports the senior and expert Data Stewards with enhancing data standards, business terms, rules, policies and processes for their functional scope, including any region-specific requirements Supports execution of defined Data Governance processes Supports compliance of defined Data policies About You Experience in Business Data Management, Information Architecture, Technology, or related fields, General knowledge of the Pharma R&D Business domains (e.g., across research, clinical, regulatory etc) Good knowledge in the Pharma R&D CMC domain – Chemistry Manufacturing and Controls domain is a plus, Ability to understand data processes in the scientific laboratory context and requirements from CMC Lab Scientists Solid grasp of data governance practices and track record of implementation, Demonstrated strong attention to detail, quality, time management and customer focus Excellent written and oral communications skills, Strong networking, influencing and negotiating skills and superior problem-solving skills Demonstrated willingness to make decisions and to take responsibility, Excellent interpersonal skills (team player) Experience in data management and data stewardship in systems used in laboratories context: electronic Lab Notebook (eLN), Laboratory Information Management System (LIMS), Scientific Information Management Systems (SDMS), Laboratory Execution System (LES) Familiar with data management practices and technologies such as: data cataloguing, data modelling & ontology management, data quality frameworks, data wrangling and visualization tools with tools such Power BI, Dataiku Agile mindset and practice Knowledge of pharma R&D industry regulations and compliance requirements related to data governance Bachelor's in computer science, Business, Engineering, Information Technology null Show more Show less

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What You Will Do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software solutions for Research scientists. Additionally, it involves automating operations, monitoring system health, and responding to incidents to minimize downtime. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements LIMS platforms that enable the capture, analysis, storage, and report of pre-clinical and clinical studies as well as those that manage biological sample banks. The ideal candidate possesses experience in the pharmaceutical or biotech industry, strong technical skills, and full stack software engineering experience (spanning SQL, back-end, front-end web technologies, automated testing). Design, develop, and implement applications and modules, including custom reports, interfaces, and enhancements Analyze and understand the functional and technical requirements of applications, solutions and systems and translate them into software architecture and design specifications Develop and execute unit tests, integration tests, and other testing strategies to ensure the quality of the software Identify and resolve software bugs and performance issues Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time Maintain detailed documentation of software designs, code, and development processes Customize modules to meet specific business requirements Work on integrating with other systems and platforms to ensure seamless data flow and functionality Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently Possesses strong rapid prototyping skills and can quickly translate concepts into working code Contribute to both front-end and back-end development using cloud technology Develop innovative solution using generative AI technologies Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations Identify and resolve technical challenges effectively Stay updated with the latest trends and advancements Work closely with product team, business team including scientists, and other stakeholders What We Expect Of You Master’s degree and 1 to 3 years of Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Bachelor’s degree and 3 to 5 years of Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Diploma and 7 to 9 years of Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field. Basic Qualifications: Proficient in C#.NET Proficient in a Javascript UI Framework (e.g. React, ExtJs) Proficient in SQL (e.g. Oracle, PostGres, Databricks) Experience with Event-based architecture (e.g. Mulesoft, AWS EventBridge, AWS Kinesis, Kafka) Preferred Qualifications: 1+ years of experience in implementing and supporting LIMS platforms Strong understanding of software development methodologies, mainly Agile and Scrum Hands-on experience with Full Stack software development Strong understanding of cloud platforms (e.g AWS) and containerization technologies (e.g., Docker, Kubernetes) Working experience with DevOps practices and CI/CD pipelines Experience with big data technologies (e.g., Spark, Databricks) Experience with API integration, serverless, microservices architecture (e.g. Mulesoft, AWS Kafka) Experience with monitoring and logging tools (e.g., Prometheus, Grafana, Splunk) Experience of infrastructure as code (IaC) tools (Terraform, CloudFormation) Experience with version control systems like Git Experience with automated testing tools and frameworks Experience with STARLIMS, Watson, LabVantage, or similar LIMS platforms Professional Certifications: AWS Certified Cloud Practitioner (preferred) Soft Skills: Excellent problem solving, analytical, and troubleshooting skills Strong communication and interpersonal skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to learn quickly & work independently Team-oriented, with a focus on achieving team goals Ability to manage multiple priorities successfully Strong presentation and public speaking skills EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. Show more Show less

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What You Will Do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software solutions for Research scientists. Additionally, it involves automating operations, monitoring system health, and responding to incidents to minimize downtime. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements LIMS platforms that enable the capture, analysis, storage, and report of pre-clinical and clinical studies as well as those that manage biological sample banks. The ideal candidate possesses experience in the pharmaceutical or biotech industry, strong technical skills, and full stack software engineering experience (spanning SQL, back-end, front-end web technologies, automated testing). Take ownership of complex software projects from conception to deployment Manage software delivery scope, risk, and timeline Possesses strong rapid prototyping skills and can quickly translate concepts into working code Contribute to both front-end and back-end development using cloud technology Develop innovative solution using generative AI technologies Conduct code reviews to ensure code quality and adherence to best practices Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations Identify and resolve technical challenges effectively Stay updated with the latest trends and advancements Work closely with product team, business team including scientists, and other stakeholders Design, develop, and implement applications and modules, including custom reports, interfaces, and enhancements Analyze and understand the functional and technical requirements of applications, solutions and systems and translate them into software architecture and design specifications Develop and execute unit tests, integration tests, and other testing strategies to ensure the quality of the software Identify and resolve software bugs and performance issues Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time Maintain detailed documentation of software designs, code, and development processes Customize modules to meet specific business requirements Work on integrating with other systems and platforms to ensure seamless data flow and functionality Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently What We Expect Of You Master’s degree and 4 to 6 years of Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Bachelor’s degree and 6 to 8 years of Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Diploma and 10 to 12 years of [Job Code’s Discipline and/or Sub-Discipline] experience Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field. Basic Qualifications: Proficient in Java Proficient in a Javascript UI Framework (e.g. React, ExtJs) Proficient in SQL (e.g. Oracle, PostGres, Databricks) Experience with event-based architecture (e.g. Mulesoft, AWS EventBridge, AWS Kinesis, Kafka) Preferred Qualifications: 3+ years of experience in implementing and supporting LIMS platforms Strong understanding of software development methodologies, mainly Agile and Scrum Hands-on experience with Full Stack software development Strong understanding of cloud platforms (e.g AWS) and containerization technologies (e.g., Docker, Kubernetes) Working experience with DevOps practices and CI/CD pipelines Experience with big data technologies (e.g., Spark, Databricks) Experience with API integration, serverless, microservices architecture (e.g. Mulesoft, AWS Kafka) Experience with monitoring and logging tools (e.g., Prometheus, Grafana, Splunk) Experience of infrastructure as code (IaC) tools (Terraform, CloudFormation) Experience with version control systems like Git Experience with automated testing tools and frameworks Experience with STARLIMS, Watson LIMS, LabVantage, or similar LIMS platforms Professional Certifications: AWS Certified Cloud Practitioner (preferred) Soft Skills: Excellent problem solving, analytical, and troubleshooting skills Strong communication and interpersonal skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to learn quickly & work independently Team-oriented, with a focus on achieving team goals Ability to manage multiple priorities successfully Strong presentation and public speaking skills EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. Show more Show less

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. IS Organizational Effectiveness Mgr What You Will Do The Scrum Master is a leader and coach who facilitates Scrum events and processes, delivering value for the Global Quality Control product team. The role involves facilitating communication and collaboration among teams, ensuring alignment with the program vision, managing risks and dependencies, and driving relentless improvement. The Scrum master helps adapt SAFe to the organization’s needs, standardizing and documenting practices. The role requires a solid background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. Roles & Responsibilities: Lead and manage product delivery using agile frameworks and techniques. Align with Agile values, such as prioritizing individuals and interactions over processes and tools. Ensure day-to-day operations by automating tasks, monitoring system health, and minimizing downtime through incident response Capture the voice of the customer to define business processes and product needs Collaborate with Global Quality business collaborators, architects, and engineering teams to prioritize release scopes and refine the product backlog Lead and facilitate breakdown of Epics into Features and sprint-sized user stories and participate in backlog reviews with the development team Clearly express features in user stories/requirements so all team members and collaborators understand how they fit into the product backlog Ensure Acceptance Criteria and Definition of Done are well-defined Advise SAFe events, including PI Planning, Scrum of Scrums, and Inspect & Adapt workshops Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators Help develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements Identify and manage risks associated with the systems, requirement validation, and user acceptance Develop & maintain documentation of configurations, processes, changes, communication plans and training plans for end users Collaborate with geographically dispersed teams, including those in the US and other international locations Foster a culture of collaboration, innovation, and continuous improvement Leverage agile tools such as Jira / Jira Align, Smartsheet’s and Confluence What We Expect Of You Must-Have Skills: Solid understanding of Agile methodologies, particularly the Scaled Agile Framework (SAFe) Prior experience with Agile project management tools, such as Jira, Confluence and Jira Align Experience in guiding teams through Agile events and ensuring consistency to SAFe practices and behaviors Good-to-Have Skills: Experience in managing product features for PI planning and developing product roadmaps and user journeys Experience maintaining SaaS (software as a system) solutions and COTS (Commercial off the shelf) solutions Technical thought leadership Able to communicate technical or complex subject matters in business terms Familiarity with GxP computer system validation Experience with Project planning/Data modelling tools such as Smartsheet, Lucid, Miro, etc. Familiarity with Quality Control platforms and Processes (LIMS, ELN, Empower) Basic Qualifications and Experience: Master’s degree with 4 - 6 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR Bachelor’s degree with 6 - 8 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR Diploma with 10 - 12 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies Professional Certifications Certified SAFe Scrum Master or similar (preferred) ITIL (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. Show more Show less

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Scientific Business Analyst (Sr Associate) – ELN What You Will Do This role involves working closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role maximizes scientific domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements scientific software platforms such as Laboratory Information Management Systems (LIMS) that enable the capture of lab workflows & experimental data and Electronic Lab Notebooks (ELN) that act as Amgen’s System of Record ensuring data integrity and business continuity. You will implement and manage scientific software platforms across the research informatics ecosystem, and provide technical support, training, and infrastructure management, and ensure it meets the needs of our Amgen Research community. Roles & Responsibilities: Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the technology ecosystem for in vivo study data management and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and breakthroughs Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 1 - 3 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Bachelor’s degree with 3 - 5years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Diploma with 7 - 9 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Demonstrated expertise in a scientific domain area and related technology needs Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience with Benchling, Revvity, IDBS, or similar LIMS/ELN platforms Preferred Qualifications: 3+ years of experience in designing and supporting biopharma scientific software platforms. Experience with Agile software development methodologies (Scrum) Experience performing or enabling data capture and analysis from instruments in a research laboratory or vivarium Ability to communicate technical or complex subject matters in business terms Knowledge of business analysis standard processes, DevOps, Continuous Integration, and Continuous Delivery methodology Experience with cloud (e.g. AWS) and on-premise infrastructure Experience designing and supporting ELN/LIMS platforms in biopharma Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills What You Can Expect Of Us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Show more Show less

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Manager Information Systems – Biological Studies What You Will Do The role will provide people leadership and project management expertise to the Biological Studies team that implements software platforms enabling the capture, analysis, storage, and report of in vitro assays and in vivo / pre-clinical studies, as well as those that manage compound inventories / biological sample banks. This individual will be responsible for developing and leading a very hardworking team that is built for delivering high-end and innovative technologies. As a scientific domain expert, this role will collaborate with cross-functional teams to identify strategies for implementation and adoption of standardized experimental data management platforms for drug discovery research. The ideal candidate will have a strong background in informatics solution delivery with a consistent record of leadership in technology-driven environments that facilitate R&D activities and has a passion for fostering innovation and excellence in the biotechnology industry. The candidate will have experience in evaluation and coaching of Technology Analysts, coupled with project management and budget management experience. Additionally, collaboration with global teams is required to ensure seamless integration and operational excellence. This role demands the ability to drive and deliver against key organizational critical initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Lead and manage diverse teams within a matrixed organization. Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Manage, grow, and develop the Biological Studies Technology team in India, ensuring global ways of working are embedded in the local organization. Provide Project Management expertise for the implementation of specialized technology platforms that enable streamlined and automated scientific data management ensuring data integrity from lab to analytics. Oversee operating budgets and product team budgets, ensuring regular review of actuals and latest estimates, managing according to agreed governance. Provide technology delivery operations leadership for Biological Studies product teams that enable systems for in vitro, in vivo, preclinical, and clinical study data management. Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities. Foster a culture of collaboration, innovation, and continuous improvement. Understand the decision-making process, workflows, and business and information needs of business partners and team members. Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, facilitating communication when service commitments are not met. Ensure communication of key performance metrics and analysis of unmet needs. Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services. Collaborate with geographically dispersed teams, including those in the US, EU, and other international locations. What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 4 - 6 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Bachelor’s degree with 6 - 8 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field Functional Skills: Must-Have Skills: 5+ years of experience in implementing and supporting biopharma scientific software platforms. Expertise in a scientific domain area and related technology needs Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data Demonstrated excellence in technology delivery operations including project management and budget management Experience building strong teams with consistent practices in a matrix organization Preferred Qualifications: Experience in a people leadership role within a pharmaceutical or technology organization Experience leading the implementation of scientific software platforms such as Electronic Lab Notebook (ELN) and Laboratory Information Management Systems (LIMS) Budget management for technology ecosystem Experience in IS governance practices for product delivery and project management Knowledge of AI and machine learning for drug discovery research and preclinical development. Experience with cloud (e.g. AWS) and on-premise infrastructure In-depth knowledge of Agile processes and principles for coordinated solutions and teams via SAFe Strong analytical/critical-thinking and decision-making abilities Ability to work effectively in a fast-paced, dynamic environment Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Excellent leadership and team management skills Strong transformation and change management experience Exceptional collaboration and communication skills High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented with a focus on achieving team goals Strong presentation and public speaking skills Ability to work effectively with global, virtual teams What You Can Expect Of Us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Show more Show less

About Amgen Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. About The Role Role Description: This role involves working closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role leverages scientific domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements LIMS platforms that enable the capture, analysis, storage, and report of pre-clinical and clinical studies as well as those that manage biological sample banks. You will collaborate with Product Owners and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. You will implement and manage scientific software platforms across the research informatics ecosystem, and provide technical support, training, and infrastructure management, and ensure it meets the needs of our Amgen Research community. Roles & Responsibilities: Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the technology ecosystem for in vivo study data management and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and milestones Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. Basic Qualifications and Experience: Master’s degree with 1 - 3 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Bachelor’s degree with 3 - 5 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Diploma with 7 - 9 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/ Bioinformatics or related field, OR Preferred Qualifications: 3+ years of experience in implementing and supporting LIMS platforms. Functional Skills: Must-Have Skills: Demonstrated expertise in a scientific domain area and related technology needs Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience in configuration and administration of LIMS platforms such as STARLIMS, Watson LIMS, LabVantage, etc. Good-to-Have Skills: Experience in the implementation of scientific software platforms, Electronic Lab Notebook (ELN), or Laboratory Information Management Systems (LIMS) Experience handling GxP data and system validation, and knowledge of regulatory requirements affecting laboratory data (e.g., FDA 21 CFR Part 11, GLP, GCP) Knowledge of bioanalytical workflows and/or biospecimen management Experience in AI and machine learning for drug discovery research and preclinical development Experience with cloud (e.g. AWS) and on-premise infrastructure In-depth knowledge of Agile processes and principles for coordinated solutions and teams via SAFe Knowledge of business analysis best practices, DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. Show more Show less

India - Hyderabad JOB ID: R-215920 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: May. 30, 2025 CATEGORY: Information Systems Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software solutions for Research scientists. Additionally, it involves automating operations, monitoring system health, and responding to incidents to minimize downtime. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements LIMS platforms that enable the capture, analysis, storage, and report of pre-clinical and clinical studies as well as those that manage biological sample banks. The ideal candidate possesses experience in the pharmaceutical or biotech industry, strong technical skills, and full stack software engineering experience (spanning SQL, back-end, front-end web technologies, automated testing). Design, develop, and implement applications and modules, including custom reports, interfaces, and enhancements Analyze and understand the functional and technical requirements of applications, solutions and systems and translate them into software architecture and design specifications Develop and execute unit tests, integration tests, and other testing strategies to ensure the quality of the software Identify and resolve software bugs and performance issues Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time Maintain detailed documentation of software designs, code, and development processes Customize modules to meet specific business requirements Work on integrating with other systems and platforms to ensure seamless data flow and functionality Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently Possesses strong rapid prototyping skills and can quickly translate concepts into working code Contribute to both front-end and back-end development using cloud technology Develop innovative solution using generative AI technologies Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations Identify and resolve technical challenges effectively Stay updated with the latest trends and advancements Work closely with product team, business team including scientists, and other stakeholders What we expect of you Master’s degree and 1 to 3 years of Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Bachelor’s degree and 3 to 5 years of Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Diploma and 7 to 9 years of Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field. Basic Qualifications: Proficient in C#.NET Proficient in a Javascript UI Framework (e.g. React, ExtJs) Proficient in SQL (e.g. Oracle, PostGres, Databricks) Experience with Event-based architecture (e.g. Mulesoft, AWS EventBridge, AWS Kinesis, Kafka) Preferred Qualifications: 1+ years of experience in implementing and supporting LIMS platforms Strong understanding of software development methodologies, mainly Agile and Scrum Hands-on experience with Full Stack software development Strong understanding of cloud platforms (e.g AWS) and containerization technologies (e.g., Docker, Kubernetes) Working experience with DevOps practices and CI/CD pipelines Experience with big data technologies (e.g., Spark, Databricks) Experience with API integration, serverless, microservices architecture (e.g. Mulesoft, AWS Kafka) Experience with monitoring and logging tools (e.g., Prometheus, Grafana, Splunk) Experience of infrastructure as code (IaC) tools (Terraform, CloudFormation) Experience with version control systems like Git Experience with automated testing tools and frameworks Experience with STARLIMS, Watson, LabVantage, or similar LIMS platforms Professional Certifications: AWS Certified Cloud Practitioner (preferred) Soft Skills: Excellent problem solving, analytical, and troubleshooting skills Strong communication and interpersonal skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to learn quickly & work independently Team-oriented, with a focus on achieving team goals Ability to manage multiple priorities successfully Strong presentation and public speaking skills EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

India - Hyderabad JOB ID: R-215926 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: May. 30, 2025 CATEGORY: Information Systems Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software solutions for Research scientists. Additionally, it involves automating operations, monitoring system health, and responding to incidents to minimize downtime. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements LIMS platforms that enable the capture, analysis, storage, and report of pre-clinical and clinical studies as well as those that manage biological sample banks. The ideal candidate possesses experience in the pharmaceutical or biotech industry, strong technical skills, and full stack software engineering experience (spanning SQL, back-end, front-end web technologies, automated testing). Take ownership of complex software projects from conception to deployment Manage software delivery scope, risk, and timeline Possesses strong rapid prototyping skills and can quickly translate concepts into working code Contribute to both front-end and back-end development using cloud technology Develop innovative solution using generative AI technologies Conduct code reviews to ensure code quality and adherence to best practices Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations Identify and resolve technical challenges effectively Stay updated with the latest trends and advancements Work closely with product team, business team including scientists, and other stakeholders Design, develop, and implement applications and modules, including custom reports, interfaces, and enhancements Analyze and understand the functional and technical requirements of applications, solutions and systems and translate them into software architecture and design specifications Develop and execute unit tests, integration tests, and other testing strategies to ensure the quality of the software Identify and resolve software bugs and performance issues Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time Maintain detailed documentation of software designs, code, and development processes Customize modules to meet specific business requirements Work on integrating with other systems and platforms to ensure seamless data flow and functionality Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently What we expect of you Master’s degree and 4 to 6 years of Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Bachelor’s degree and 6 to 8 years of Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Diploma and 10 to 12 years of [Job Code’s Discipline and/or Sub-Discipline] experience Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field. Basic Qualifications: Proficient in Java Proficient in a Javascript UI Framework (e.g. React, ExtJs) Proficient in SQL (e.g. Oracle, PostGres, Databricks) Experience with event-based architecture (e.g. Mulesoft, AWS EventBridge, AWS Kinesis, Kafka) Preferred Qualifications: 3+ years of experience in implementing and supporting LIMS platforms Strong understanding of software development methodologies, mainly Agile and Scrum Hands-on experience with Full Stack software development Strong understanding of cloud platforms (e.g AWS) and containerization technologies (e.g., Docker, Kubernetes) Working experience with DevOps practices and CI/CD pipelines Experience with big data technologies (e.g., Spark, Databricks) Experience with API integration, serverless, microservices architecture (e.g. Mulesoft, AWS Kafka) Experience with monitoring and logging tools (e.g., Prometheus, Grafana, Splunk) Experience of infrastructure as code (IaC) tools (Terraform, CloudFormation) Experience with version control systems like Git Experience with automated testing tools and frameworks Experience with STARLIMS, Watson LIMS, LabVantage, or similar LIMS platforms Professional Certifications: AWS Certified Cloud Practitioner (preferred) Soft Skills: Excellent problem solving, analytical, and troubleshooting skills Strong communication and interpersonal skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to learn quickly & work independently Team-oriented, with a focus on achieving team goals Ability to manage multiple priorities successfully Strong presentation and public speaking skills EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

India - Hyderabad JOB ID: R-215907 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: May. 30, 2025 CATEGORY: Information Systems Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. IS Organizational Effectiveness Mgr What you will do The Scrum Master is a leader and coach who facilitates Scrum events and processes, delivering value for the Global Quality Control product team. The role involves facilitating communication and collaboration among teams, ensuring alignment with the program vision, managing risks and dependencies, and driving relentless improvement. The Scrum master helps adapt SAFe to the organization’s needs, standardizing and documenting practices. The role requires a solid background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. Roles & Responsibilities: Lead and manage product delivery using agile frameworks and techniques. Align with Agile values, such as prioritizing individuals and interactions over processes and tools. Ensure day-to-day operations by automating tasks, monitoring system health, and minimizing downtime through incident response Capture the voice of the customer to define business processes and product needs Collaborate with Global Quality business collaborators, architects, and engineering teams to prioritize release scopes and refine the product backlog Lead and facilitate breakdown of Epics into Features and sprint-sized user stories and participate in backlog reviews with the development team Clearly express features in user stories/requirements so all team members and collaborators understand how they fit into the product backlog Ensure Acceptance Criteria and Definition of Done are well-defined Advise SAFe events, including PI Planning, Scrum of Scrums, and Inspect & Adapt workshops Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators Help develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements Identify and manage risks associated with the systems, requirement validation, and user acceptance Develop & maintain documentation of configurations, processes, changes, communication plans and training plans for end users Collaborate with geographically dispersed teams, including those in the US and other international locations Foster a culture of collaboration, innovation, and continuous improvement Leverage agile tools such as Jira / Jira Align, Smartsheet’s and Confluence What we expect of you Must-Have Skills: Solid understanding of Agile methodologies, particularly the Scaled Agile Framework (SAFe) Prior experience with Agile project management tools, such as Jira, Confluence and Jira Align Experience in guiding teams through Agile events and ensuring consistency to SAFe practices and behaviors Good-to-Have Skills: Experience in managing product features for PI planning and developing product roadmaps and user journeys Experience maintaining SaaS (software as a system) solutions and COTS (Commercial off the shelf) solutions Technical thought leadership Able to communicate technical or complex subject matters in business terms Familiarity with GxP computer system validation Experience with Project planning/Data modelling tools such as Smartsheet, Lucid, Miro, etc. Familiarity with Quality Control platforms and Processes (LIMS, ELN, Empower) Basic Qualifications and Experience: Master’s degree with 4 - 6 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR Bachelor’s degree with 6 - 8 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR Diploma with 10 - 12 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies Professional Certifications Certified SAFe Scrum Master or similar (preferred) ITIL (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

India - Hyderabad JOB ID: R-215922 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: May. 30, 2025 CATEGORY: Information Systems ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description: We are seeking a highly skilled Associate IS Bus Sys Analyst to join our Quality Control Product team. You will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime. Roles & Responsibilities: Maintain existing code and configuration: Support and maintain Quality Control applications Development & Deployment: Develop, test, and deploy code based on designs created with the guidance of senior team members. Implement solutions following standard methodologies for code structure and efficiency. Documentation: Generate clear and concise code documentation for new and existing features to ensure smooth handovers and easy future reference. Collaborative Design: Work closely with team members and collaborators to understand project requirements and translate them into functional technical designs. Code Reviews & Quality Assurance: Participate in peer code reviews, providing feedback on adherence to standard methodologies, and ensuring high code quality and maintainability. Testing & Debugging: Assist in writing unit and integration tests to validate new features and functionalities. Support fix and debugging efforts for existing systems to resolve bugs and performance issues. Perform application support and administration tasks such as periodic review, manage incident response and resolution, and security reviews. Continuous Learning: Stay up-to-date with the newest technologies and standard methodologies, with a focus on expanding knowledge in cloud services, automation, and secure software development. What we expect of you Must-Have Skills Solid technical background, including understanding software development processes, databases, and cloud-based systems. Experience configuring Quality Control Platforms (LIMS, ELN, Empower CDS) Experience working with databases, data modeling and data warehousing (Oracle, MySQL). Strong foundational knowledge of testing methodologies. Good-to-Have Skills: Understanding of Quality Control Process. Curiosity of modern technology domain and learning agility Experience with the following technologies: AWS (Amazon Web Services) Services (DynamoDB, EC2, S3, etc.), Application Programming Interface (API) integration and Structured Query Language (SQL), Remote desktop application access management (Citrix Workspace, Middleware Experience (Mulesoft, Datadobi). Superb communication skills, with the ability to convey complex technical concepts. Professional Certifications NA Soft Skills: Excellent analytical and problem-solving skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Basic Qualifications: Bachelor’s degree and 1to 3 years of Computer Science, IT or related field experience OR Diploma and 4 to 7years of Computer Science, IT or related field experience EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

· Receipt of sample Data entry of sample receipt information, Sample review and its record preparation.-1 · Sample repacking wherever possible, coding and issue of sample through the software and or manually.-1 · Collection and data entry of various sample analysis information,-1 · Report preparation, making analysis report to be sent to customer through LIMS. Preparation of weekly, monthly progress report of samples receipt, analysis & out of specification.-1 Work Remotely No Job Types: Full-time, Permanent Pay: ₹10,000.00 - ₹15,000.00 per month Benefits: Health insurance Schedule: Day shift Experience: Data entry: 1 year (Preferred)

About Envirocare Labs Envirocare Labs is a premier NABL-accredited laboratory with over 45 years of excellence in analytical testing, inspection, and certification services. Recognized by FSSAI, BIS, APEDA, AGMARK, and other regulatory bodies, we specialize in food, water, environmental, and pharmaceutical testing. Our Goa facility is equipped with state-of-the-art instrumentation and staffed by a team of dedicated scientists committed to quality and precision. Job Purpose The Food Analyst will be responsible for the end-to-end handling and release of regulatory samples received from FSSAI, FDA, and other authorities. This role requires strong analytical acumen, attention to detail in documentation, strict adherence to regulatory protocols, and effective coordination with internal and external stakeholders to ensure compliance with FSSR and other applicable standards. Key Responsibilities Review and verify accompanying documentation for regulatory samples received from authorities. Coordinate with officials for any clarifications required. Categorize samples upon receipt and assign relevant testing parameters in accordance with FSSR, surveillance plans, or specific instructions from regulatory bodies. Ensure that all testing procedures are performed strictly in accordance with approved protocols and regulatory standards. Conduct verification and authorize final reports as per the requirements of FSSR, clearly indicating compliance or non-compliance with applicable food standards. Oversee proper handling, storage, retention, and timely disposal of regulatory samples in line with SOPs. Ensure turnaround times (TAT) are met as per requirements for import, legal, and surveillance samples. Manage timely uploading of completed reports onto the Infolnet portal following analysis. Collaborate with Microbiology and Instrumentation teams to ensure timely testing and integrated reporting. Participate in the submission of regulatory data, including monthly testing summaries, feasibility responses, and other official communications as required by FSSAI or FDA. Supervise laboratory personnel engaged in food testing activities and ensure adherence to quality protocols. Review test results generated by junior analysts and technicians for completeness and accuracy. Train and mentor team members on regulatory testing methodologies and best practices. Stay updated with changes in FSSAI guidelines, methods, and relevant national/international food laws to ensure continuous compliance. Qualifications Educational Background: Master’s degree in Chemistry (Analytical, Organic, or Inorganic), B.Tech in Food Technology, or any other degree with specialization in Food Technology. Experience: 3-5 years of relevant experience of working as a FSSAI Food Analyst Required Skills Analytical Skills: Proficiency in conducting chemical and microbiological analyses. Time Management: Ability to manage multiple tasks efficiently and meet deadlines. Attention to Detail: Meticulous in documentation and adherence to protocols. Team Collaboration: Effective communication and teamwork abilities Preferred Skills Familiarity with laboratory instruments such as HPLC, GC-MS, and ICP-MS. Knowledge of food safety standards and regulations (e.g., FSSAI guidelines). Experience with Laboratory Information Management Systems (LIMS). Job Type: Full-time Pay: ₹300,000.00 - ₹500,000.00 per year Benefits: Health insurance Paid sick time Provident Fund Schedule: Fixed shift Rotational shift Work Location: In person

Project Assistant (LIMS | 0-1 yr (Fresher)) – Night Shift – Delhi-NCR / Remote Hybrid Requirement: Knowledge of LIMS (Laboratory Information Management Systems) is plus Degree in Biology, Biochemistry, Biotechnology, or a related field. Salary: ₹20K per month Fixed Location: Flexible (Onsite/Remote Hybrid Possible) Experience: Fresher (0–1 Years) Working Hours: Can be Fully or Partially Night Shift (to support USA-based clients) About the Role: We are seeking a Project Assistant with an academic background in Biology, Biochemistry, Biotechnology, or related fields . The ideal candidate will support clients using our Laboratory Information Management System (LIMS), assist with client training and onboarding, and serve as a liaison between the client and the technical team. Key Responsibilities: Client Follow-up & Communication: Maintain regular contact with clients for updates, feedback, and support. LIMS Demos: Conduct LIMS product demonstrations for clients (primarily in the USA). Client Onboarding: Guide new clients through setup, onboarding, and system usage. Support & Training: Respond to client issues and provide functional support to ensure smooth LIMS usage. Documentation: Maintain documentation of client requirements, queries, and system usage. Team Coordination: Relay client issues and feature requests to the internal technical team. Requirements: Familiarity with LIMS (Laboratory Information Management Systems) is prefered. Degree in Biology, Biochemistry, Biotechnology, or a related field . Strong communication skills and willingness to interact directly with clients. Basic understanding of laboratory workflows is a plus. Willingness to work flexible hours , including night shifts to support USA-based clients. Technical Skills: Understanding of Laboratory Information Management Systems (LIMS) is a plus. Join Us: If you are enthusiastic about biology and enjoy supporting clients in a technical capacity, we look forward to welcoming you to our team. How to Apply: Please share your CV at hr@ipseity.bio along with your notice period, current CTC, and expected CTC. For more info, please visit: https://ipseity.bio/ #ProjectAssistant #LIMS #ClientSupport Show more Show less

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. This position is responsible for Conducting laboratory testing, not limited to validation, verification, transfer, and registration stability studies. The successful candidate shall possess solid “hands-on” technical abilities, a passion for their work and the impact it has on meeting the needs of patients. Effectively contributing technical knowledge and skills to a variety of projects by conducting testing, designing analytical method and experiments. Interacting effectively with a variety of disciplines (Quality, Regulatory, External partners etc.). Conducting routine research and design experiments, independently developing/evaluating/validating and/or transferring analytical methods. Essential Duties And Responsibilities Collect information for the analytical target profile. Propose techniques and develop analytical methods independently. Design studies and write protocols, reports, and procedures with minimal guidance. Evaluation, validation, or transfer of analytical methods, including investigating failed acceptance criteria. Contribute routine scientific knowledge or expertise to research and development activities for achievement of project goals. Evaluation of current methods and devise new approaches through adaptations and incorporation of new technologies to meet business objectives such as quality and cycle-time. Independently conduct routine research and developmental activities. Plan details of assigned tasks within specific parameters. Employ appropriate techniques and methods to successfully conduct assignments within negotiated deadlines after receiving general instruction. Perform laboratory testing in a regulated environment. Demonstrate working knowledge of basic technical theories and principles within area of expertise for routine tasks. Develop knowledge and understanding of GxP and related regulations and guidance. Conduct R&D stability testing as per the stability protocol to support registration of R&D Product. Independently execute analytical method validations and transfers with minimal support. Accurately test the samples (Right First Time) and assess results for conformance to specifications. Manage Laboratory investigations (OOS/OOT), Nonconformance/deviations to identify sound scientific root cause to follow the implemented corrective and Preventive actions. Sample receiving and data entry in LIMS. Adhere to cGxP requirements (ALCOA+), Data Integrity, Quality Culture and Compliance Level. Own SOPs of relevant techniques / procedures. Advise and troubleshoot issues and propose solutions. Maintain lab equipment and report on malfunctions. Good knowledge of laboratory health and safety standards. Demonstrate the ability to identify risks, issues, and identify opportunities for improvement of existing processes, technologies, and approaches by providing sound scientific rationale. Maintain knowledge of relevant QSR and other regulatory requirements related to R&D to ensure compliance in all research, data collection and reporting activities. Collaborate with global teams across various functions (ex. quality, regulatory, operations, manufacturing, etc.). Analyze data, make decisions, and present status at technical review meetings. Design studies and autonomously write protocols, reports, and procedures with minimum guidance. Support in writing responses to authorities’ questions on analytical methods. Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. Show more Show less

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Vantive: A New Company Built on Our Legacy Since last year, we have been on a journey to separate our Kidney Care segment into a standalone company. Vantive will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support. Job Summary Job Title –Research Associate I Location – Whitefield, Bangalore Shift – General Job Responsibilities Conducting laboratory testing, not limited to validation, verification, transfer, and registration stability studies. The successful candidate shall possess solid “hands-on” technical abilities, a passion for their work and the impact it has on meeting the needs of patients. Effectively contributing basic technical knowledge and skills to a variety of projects within relevant disciplines. Interacting effectively with a variety of disciplines. Conducting routine research and design experiments with minimum assistance. Essential Duties And Responsibilities Collect information for the analytical target profile. Propose techniques and develop analytical methods independently or with minimum support. Design studies and write protocols, reports, and procedures with minimal guidance. Participate in evaluation, validation, or transfer of analytical methods, including investigating failed acceptance criteria. Contribute routine scientific knowledge or expertise to research and development activities for achievement of project goals. Under direction, conduct routine research, developmental activities. Plan details of assigned tasks within specific parameters. Understand and apply applicable corporate and divisional SOPs. Employ appropriate techniques and methods to successfully conduct assignments within negotiated deadlines after receiving general instruction. Perform laboratory testing in a regulated environment. Demonstrate working knowledge of basic technical theories and principles within area of expertise for routine tasks. Develop knowledge and understanding of GxP and related regulations and guidance. Conduct R&D stability testing as per the stability protocol to support registration of R&D Product. Execute analytical method validations and transfers with minimal support. Accurately test the samples (Right First Time) and assess results for conformance to specifications. Support Laboratory investigations (OOS/OOT), Nonconformance/deviations to identify sound scientific root cause to follow the implemented corrective and Preventive actions. Sample receiving and data entry in LIMS. Adhere to cGxP requirements (ALCOA+), Data Integrity, Quality Culture and Compliance Level. Ownership of SOPs of relevant techniques / procedures. Troubleshoot issues and propose solutions. Maintain lab equipment and report on malfunctions. Good knowledge of laboratory health and safety standards. Demonstrate the ability to identify risks, issues, and identify opportunities for improvement of existing processes, technologies, and approaches by providing sound scientific rationale. Collaborate with global teams across various functions (ex. quality, regulatory, operations, manufacturing, etc.). Maintain knowledge of relevant QSR and other regulatory requirements related to R&D to ensure compliance in all research, data collection and reporting activities. Qualifications Knowledge of regulatory validation & stability guidelines and skills for testing products within relevant discipline. Possess relevant practical knowledge on analytical techniques like HPLC/UPLC, GC, Titrations, AAS etc., Possess relevant laboratory/technical, writing, and computer skills. Able to work in a team environment appropriately supporting others. Self-motivated and takes personal responsibility for getting the job done. Ability to objectively assess, organize, and clearly communicate complex information. Understand the importance of project schedules and contribute to efforts beyond own scope of responsibilities to ensure project milestones are met. Ability to adapt to shifting priorities. Ability to demonstrate critical thinking and problem-solving skills. Handling of software like Empower, Chromeleon, LIMS etc., Good learning agility and communication skills. Possessing relevant computer and technical skills including M.S word, spreadsheets etc. Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. Show more Show less

Streamline the data review process across all GxP systems, including CDS, FTIR, UV, KF, LIMS, MES, and more. Pro CDS Hub Our Vision for Digital Manufacturing & Future Quality Control Pro ExtractEase Pro ExtractEase automates data extraction from Empower to facilitate insights from the data. Pro Das Is a versatile platform tailored to automate the Project Creation, Back-up/Restoration activities of Empower. Pro QMSuite Is a system that documents the policies, procedures, and controls necessary for an organization

Line of Service Advisory Industry/Sector Not Applicable Specialism SAP Management Level Associate Job Description & Summary At PwC, our people in business application consulting specialise in consulting services for a variety of business applications, helping clients optimise operational efficiency. These individuals analyse client needs, implement software solutions, and provide training and support for seamless integration and utilisation of business applications, enabling clients to achieve their strategic objectives. As a SAP consulting generalist at PwC, you will focus on providing consulting services across various SAP applications to clients, analysing their needs, implementing software solutions, and offering training and support for effective utilisation of SAP applications. Your versatile knowledge will allow you to assist clients in optimising operational efficiency and achieving their strategic objectives. Why PWC At PwC, you will be part of a vibrant community of solvers that leads with trust and creates distinctive outcomes for our clients and communities. This purpose-led and values-driven work, powered by technology in an environment that drives innovation, will enable you to make a tangible impact in the real world. We reward your contributions, support your wellbeing, and offer inclusive benefits, flexibility programmes and mentorship that will help you thrive in work and life. Together, we grow, learn, care, collaborate, and create a future of infinite experiences for each other. Learn more about us. At PwC, we believe in providing equal employment opportunities, without any discrimination on the grounds of gender, ethnic background, age, disability, marital status, sexual orientation, pregnancy, gender identity or expression, religion or other beliefs, perceived differences and status protected by law. We strive to create an environment where each one of our people can bring their true selves and contribute to their personal growth and the firm’s growth. To enable this, we have zero tolerance for any discrimination and harassment based on the above considerations. " Job Description & Summary Objective of the Role: Responsibilities: you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: SAP QM consultant with minimum 2-10 year’s experience with minimum 1-2 end to end implementation experience. Must have worked in Inward inspection, In Process Inspection, Quality Assurance, Integration with LIMS and QMS, Stability test, Recurring inspection, Inspection Label printing, Certificate of Analysis, Quality characteristics, Inspection scenarios. Domain knowledge in Quality management would be preferred. Mandatory Skills: SAP PP/QM, S4HANA, E2E implementation Person Specification: Highly confident with providing to support users Strong attention to detail and a keen to desire deliver the highest quality solutions to customers. Solves complex problems with creative solutions / proposals Self-Starter with ability to handle multiple tasks and shifting priorities Required Skills and Qualifications: Preferred Skills: SAP PP/QM, S4HANA, Consulting experience Years of Experience: 2-10 years of experience Education: B.Tech. /B.E. /MBA /M.Tech./M.E./MCA/CA/CMA/ICWA Education (if blank, degree and/or field of study not specified) Degrees/Field of Study required: Bachelor of Engineering, Master of Engineering Degrees/Field Of Study Preferred: Certifications (if blank, certifications not specified) Required Skills SAP FICO Optional Skills SAP S/4HANA Cloud Public Sales Desired Languages (If blank, desired languages not specified) Travel Requirements Not Specified Available for Work Visa Sponsorship? No Government Clearance Required? No Job Posting End Date Show more Show less

Department: Analytical Development Injectables / Complex Injectables US Market Job Description: Method Development of Drug Product and Method verification of Raw Materials using HPLC, UHPLC with sound knowledge of Chromeleon & Lab solution software. To perform analysis of Drug Product and Drug Substances for various test parameters and as per the product development requirement. Compilation of analytical results and preparation Method Development Report. Literature survey to support method development of Drug product and characterization activity of Drug product. Compilation and monitoring of routine and stability analysis data. Support to formulation team to develop the drug product.

India - Hyderabad JOB ID: R-214545 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: May. 13, 2025 CATEGORY: Information Systems Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Scientific Business Analyst (Sr Associate) – ELN What you will do This role involves working closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role maximizes scientific domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements scientific software platforms such as Laboratory Information Management Systems (LIMS) that enable the capture of lab workflows & experimental data and Electronic Lab Notebooks (ELN) that act as Amgen’s System of Record ensuring data integrity and business continuity. You will implement and manage scientific software platforms across the research informatics ecosystem, and provide technical support, training, and infrastructure management, and ensure it meets the needs of our Amgen Research community. Roles & Responsibilities: Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the technology ecosystem for in vivo study data management and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and breakthroughs Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 1 - 3 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Bachelor’s degree with 3 - 5years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Diploma with 7 - 9 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Demonstrated expertise in a scientific domain area and related technology needs Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience with Benchling, Revvity, IDBS, or similar LIMS/ELN platforms Preferred Qualifications: 3+ years of experience in designing and supporting biopharma scientific software platforms. Experience with Agile software development methodologies (Scrum) Experience performing or enabling data capture and analysis from instruments in a research laboratory or vivarium Ability to communicate technical or complex subject matters in business terms Knowledge of business analysis standard processes, DevOps, Continuous Integration, and Continuous Delivery methodology Experience with cloud (e.g. AWS) and on-premise infrastructure Experience designing and supporting ELN/LIMS platforms in biopharma Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

India - Hyderabad JOB ID: R-214289 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Apr. 29, 2025 CATEGORY: Quality Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let’s do this. Let’s change the world. In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities. Responsibilities Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Serve as Owner or QA Contact for handling the Deviations. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to management’s attention and initiate and enforce necessary improvements and corrections to established systems and processes. Initiate, implement, and track completion of Change Control and deviation requests related to computer systems. Participation and support of regulatory inspections. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will be required to go into the office as dictated by the site policy. Validation Validation Documentation: Review and approve all validation documentation, ensuring compliance with regulatory requirements and internal quality standards. Requirement Specifications & Test Protocols: Review and approve Requirement Specifications, Design Specifications, Test Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices. System Life Cycle Documents: Review and approve System Life Cycle Documents (e.g., test protocols) prior to their use in production. Data Integrity Assessments: Review and approve Data Integrity Assessments to ensure data is accurate and complies with regulatory standards. Change Control Management: Initiate, review, and approve Change Control requests, acting as the QA contact for changes in systems (e.g Trackwise/Veeva , ServiceNow) Periodic Review/Audit Trail System Periodic Reviews & Audit Trails: Review and approve periodic system reviews and audit trail reports to ensure system integrity and compliance. Supplier Management Supplier Evaluations : Provide support for supplier evaluations as needed, ensuring suppliers meet quality, compliance, and performance standards. Deviation & CAPA Management: Initiate and manage deviations (major and minor) as required. Serve as the primary QA contact for deviations, ensuring proper investigation and resolution. Act as the quality reviewer and approve for problem records in ServiceNow, ensuring that all records meet internal quality standards. CAPA & Effectiveness Verification (EV): Serve as the QA contact or owner for Corrective and Preventive Actions (CAPA) and Effectiveness Verification (EV) records, ensuring timely and effective resolution. Responsible as a Business Owner for overseeing and managing specific GxP Computerized Systems programs and projects, ensuring compliance with regulatory standards and alignment with business objectives. Independently develop solutions that are thorough, practical and consistent with functional objectives. Review and approve operational and administrative Standard Operating Procedures (SOPs) and Work Instructions, ensuring alignment with regulatory and quality standards. Apply analytical skills to evaluate complex problems, utilizing both qualitative and quantitative data, including trend analysis, to develop effective solutions. Contributes to continuous improvement efforts and initiatives. Assists with training initiatives and strategy as required. Provides support for the Management Review Process when needed. Supports the Integrated Systems Assessment (ISA) Process as necessary. Participates in and aids with regulatory inspections as required. What we expect from you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with a minimum of 7 years experience in Software and Systems Quality assurance OR Bachelor’s degree with a minimum of 10 years of Software and Systems Quality assurance experience Preferred Qualifications: Strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards. Proven experience in the validation of computerized systems and strong understanding and application of GxP regulations (GMP, GLP, GCP, GPvP, GDP). Experience managing quality assurance processes, including Change controls, Deviations, CAPAs and effectiveness checks. Demonstrated ability to handle and resolve complex quality issues using analytical and problem-solving skills. Strong decision-making abilities with the capacity to drive tasks to completion. Ability to work independently with minimal supervision. Leadership skills with experience leading projects, teams, or tasks. Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise , Documentation Management Systems, LIMS, SAP and Maximo. Broad technical expertise within specialty area and familiarity with industry standards. Ability to provide training, guidance, and contribute to team quality. Works closely with leadership / senior staff and external experts to extend capabilities and enhance performance. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

India - Hyderabad JOB ID: R-211223 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Mar. 28, 2025 CATEGORY: Information Systems Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Scientific Business Analyst (Associate) – ELN What you will do This role involves working closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role leverages scientific domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements scientific software platforms such as Laboratory Information Management Systems (LIMS) that enable the capture of lab workflows & experimental data and Electronic Lab Notebooks (ELN) that act as Amgen’s System of Record ensuring data integrity and business continuity. You will implement and manage scientific software platforms across the research informatics ecosystem, and provide technical support, training, and infrastructure management, and ensure it meets the needs of our Amgen Research community. Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the technology ecosystem for in vivo study data management and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and landmarks Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Bachelor’s degree with 0 - 3 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Diploma with 4 - 7years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Demonstrated expertise in a scientific domain area and related technology needs Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience with Benchling, Revvity, IDBS, or similar LIMS/ELN platforms Preferred Qualifications: Experience with Agile software development methodologies (Scrum) Experience performing or enabling data capture and analysis from instruments in a research laboratory or vivarium Ability to communicate technical or complex subject matters in business terms Knowledge of business analysis standard processes, DevOps, Continuous Integration, and Continuous Delivery methodology Experience with cloud (e.g. AWS) and on-premise infrastructure Experience supporting ELN/LIMS platforms in biopharma Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.