24 Eln Jobs

Purpose of the Role: To conduct research under guidance of Group Lead/Team Lead to optimse the cost and improve the yield to aid in the business growth of UPL. Job Responsibilities: 1. To set up reactions based on discussion and planning with Team Leader to optimise synthesis of out of patent agrochemical intermediates and active ingredient. 2. To carry out reactions in lab for development of non-infringing processes and improve cost effectiveness of existing products by improving yield, modifying processes and maintaining quality, monitoring and concluding based on analysis. 3. Communicate on daily basis on the progress of the project. 4. Achieve reproducibility and consistency of results. Maintain daily records and update for QMS system 5. Follow safe handling practices of chemicals and reactions to maintain industrial hygiene and reduce environmental wastes. 6. Tabulate data of experiments needed for review meeting. 7. Maintenance of Equipment's or Instruments given under laboratory control. Collaborate with other divisions for related work. 8. Recording experiment details in ELN Qualification: a) M.Sc. in Organic Chemistry with 2-4 yrs of experience

Role: ELN/Biovia support Department : IT Location : Hyderabad About Us: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace diversity and follow equal opportunity practices across all levels. Roles and Responsibilities: Understand the informatics (ELN , CDS) needs of Labs and provide support of informatics Applications. Coordinate between scientists and vendor for any solution development. Implement new solutions/applications and provide support for existing scientific applications running at Sai. Facilitates computer system validation and ensures that scientific applications are always in validated state. Key Responsibilities : Candidate should have good understanding of Chemistry and biology pharma R&D lab. Candidate should have exposure of lab computing support in handling lab instruments needs. Candidate should have implementation experience of Electronic Lab notebooks (ELN) preferably Biovia or Perkin Elmer Candidate should be familiar with GMP guidelines. Experience in demonstrating a track record of delivering scientific solutions in the pharmaceutical and CRO industry. Experience in the implementation of Informatic applications like (Electronic Laboratory Notebooks(elNB), Laboratory Information Management System, Chromatography Data system (CDS) and other scientific applications. Experience in working with Data acquisition layer /Comprehensive Data Management /Data Lake/ Data Mart (Data Warehouse) and Scientific Data Management System (SDMS). Experience: Demonstrated track record in delivering scientific solutions preferably in a pharmaceutical and biotechnology industry. Industry experience 4-9 years desired. Key Competencies (Technical, Functional & Behavioral): 1. Good communication skills 2. Demonstrate ownership and collaboration at work

Job Opening : LabWare LIMS Developer (3 -12 Years Experience) Share your resumes to Arun.g@ltimindtree.com Location: Bangalore, Pune , Hyderabad , Chennai Experience: 3-12 years Employment Type: Full-time About the Role We are seeking a seasoned LabWare LIMS Developer to join our dynamic team supporting global pharmaceutical and clinical laboratory operations. This role demands strong technical expertise in LabWare LIMS (v6/v7/v8), stakeholder management, and a deep understanding of pharma domain processes. Role & responsibilities Develop and implement custom configurations tailored to lab workflows. Integrate instruments and third-party applications (e.g., Chromeleon, Empower, SAP, ERP) with LabWare LIMS. Manage static data, system upgrades, and validation activities. Troubleshoot performance issues and conduct system/application log analysis. Collaborate with global teams and stakeholders across time zones. Ensure 24x7 application availability and support. Conduct GxP analysis, gap/risk assessments, and ensure 21 CFR Part 11 compliance. Lead and mentor a team of 1215 engineers, balancing technical (75%) and managerial (25%) responsibilities. Required Skills Strong hands-on experience with LabWare LIMS v6/v7/v8 and ELN/Method Execution modules. Proficient in LIMS Basic coding, debugging, and Crystal Reports configuration. Expertise in LabWare modules: Product, Lot, EM, Stability, Inventory, Sample Management, LabStation. Solid understanding of LabWare architecture, database structures, and Oracle PL/SQL. Familiarity with SDLC, Agile, ITIL, ITSM, and SNOW ticketing/reporting systems. Experience with CAPA, TrackWise, Documentum, HP ALM, and SOP/WI creation. Excellent verbal and written communication skills. Interested? Apply now or reach out for more details. Lets build the future of lab informatics together! Share your resumes to Arun.g@ltimindtree.com

Date: 12 Aug 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Essential Functions Job Description Job Title: Senior Analyst Job Location: Syngene International Limited, Bengaluru About Syngene: Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to companys integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose Of The Role This is an exciting opportunity to play a role in the Quality control department of Syngene. The role will provide several responsibilities of Analysis, documentation, Lab safety requirements, Compliance as per Syngene policy and EHSS requirement. It provides an opportunity to handle overall analysis of QC and Stability samples. Role Accountabilities Analysis of Raw Material/ In process samples/ cleaning samples/ Intermediate samples/Finished product/water sample/ Packaging materials/ Formulation finished products and management/traceability of Reserve samples and Visual inspection samples. Maintenance of sampling tools as per the standard operating procedure. Packing and Maintenance of reserve samples and visual inspection samples as applicable Carry out the analysis on the qualified techniques as per the approved specification/protocol/procedures and Interpret the data from analytical instruments and report the results and submit the completed documents for review promptly. Preparation of Certificate of analysis Recording of analytical observations/ findings, reporting of data and results in observation data sheets, forms, logbooks, LIMS and ELN application softwares. Reporting of any abnormal observation identified during analysis to reporting manager/Group leader/HOD immediately. Calibration of Instruments and perform HPLC lamp intensity test as per schedule, hot water flushing of HPLC and general preventive checks for laboratory instruments. Creation/ preparation of documents, master data/ static data creation in LIMS, ELN and LMS Softwares as applicable. Initiation of QMS elements and other documents in Trackwise and EDMS application softwares. Record updation for Outsourcing of sample testing based on requirement and updating respective Logbooks. Coordination with engineering & maintenance and external vendor for preventive maintenance and calibration activity. Initiation of Change control, CAPA, deviation, Laboratory Incident, OOS, OOT, Non-Conformity as applicable. Disposal of left-over Sample after review/approval of analytical report /Release. To indent the chemicals, glassware, document, instrument, and accessories required for performing analysis as per the plan. Archive and retrieve documents related to the section. Adherence to Good Laboratory Practice and Good documentation practices. Cleaning of workplace and following Good Laboratories Practices while working in QC Laboratory. Individuals working in the GMP environment are responsible for documenting/record the activities contemporaneously and accurately as per Good documentation practices. Handling of LMS, LIMS, ELN, TrackWise and EDMS Softwares for routine activities as applicable. Responsible for taking any other job allocated by Head QC / Group Leader /Section Head/ Section In-Charge. In addition, the responsibility of the standard management team as; Receipt, Inventory management, Qualification, Labeling, Dispensing of Analytical standards, removal and disposal of expiry standards and Storage of standards as per the appropriate storage condition used in Quality Control Laboratory. Review the status of Pharmacopoeial reference standards and their validity periodically. Preparation of Standard Qualification protocol, Report and COA as applicable. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience: 3-6 years Skills And Capabilities Expertise in handling multiple Instruments/ equipment like HPLC, Dissolution tester, KF, and GC. Capable of thinking scientifically to address complex problems and develop solutions. Work as a team and have a collaborative mindset. Good communication skills. Education: MSC/ B. Pharma Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Show more Show less

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 Handle 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 handle 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. Develop a culture of collaboration, innovation, and continuous improvement. Basic Qualifications: Bachelor s degree and 2 to 6 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field 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. Preferred Qualifications: 1+ years of experience in implementing and supporting LIMS platforms 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

We are seeking an experienced ELN (Benchling, iLab, Biovia & Lab Informatics) Product Owner with strong domain expertise in electronic lab notebook (ELN) platforms, especially Benchling and Biovia. This role will serve as the functional lead responsible for defining the product vision and working closely with scientific and technical teams within Pharma or Life Sciences organizations to drive ELN development, integration, and adoption. Key Responsibilities Define and manage product vision, roadmap, and backlog for ELN solutions Gather and prioritize business and scientific requirements from R&D and lab users Collaborate with cross-functional technical teams to lead ELN development and customization Ensure seamless integration of ELN systems with LIMS, CDS, SDMS, and other lab informatics platforms Align ELN solutions with regulatory frameworks (e.g., GxP, ALCOA+) and industry standards Drive stakeholder engagement and support user onboarding through training and documentation Act as liaison between business and development teams to ensure product alignment and value delivery Primary Skills Product ownership and lifecycle management for ELN platforms Hands-on expertise with Benchling and Biovia Requirement gathering and backlog management Familiarity with lab informatics systems: LIMS, CDS, SDMS Knowledge of Pharma/Life Sciences domain practices and workflows Understanding of regulatory compliance standards: GxP, ALCOA+ Strong stakeholder engagement and cross-team collaboration Secondary Skills Business analysis experience in life sciences or pharmaceutical R&D Experience with user training and documentation processes Agile product development methodologies Excellent communication and presentation skills Preferred Qualifications Bachelors or Masters degree in Life Sciences, Pharmaceutical Sciences, or a related field 4+ years of experience in product ownership, business analysis, or platform integration roles Prior experience managing ELN initiatives for Pharma or Life Sciences organizations Proven track record of successfully delivering lab informatics solutions.

Role & responsibilities Lead end-to-end project management for IT/technology initiatives in the pharma/life sciences domain, ensuring timely delivery and within budget. Collaborate with cross-functional teams including R&D, Quality, Manufacturing, Regulatory, and Commercial teams. Define project scope, objectives, deliverables, milestones, and timelines. Manage vendor coordination, software implementation, system integration, and infrastructure deployments. Ensure alignment of projects with industry regulations such as GxP, CFR Part 11, HIPAA, GDPR, etc. Prepare detailed project plans, status reports, risk mitigation strategies, and issue logs. Act as a single point of contact for stakeholders, ensuring effective communication and expectation management. Facilitate change management, training, and adoption strategies. Ensure adherence to internal project governance, compliance, and validation procedures. Preferred candidate profile 1012 years of total experience in IT/Technology Project Management, with at least 5 years in the Pharma/Life Sciences domain. Proven experience managing technology transformation, digital health, lab systems (e.g., LIMS, ELN), clinical systems (e.g., CTMS), manufacturing systems or similar. Strong understanding of regulatory environments and compliance standards (FDA, GxP, CSV, etc.). Hands-on experience with Agile, Scrum, or Hybrid delivery methodologies. Ability to manage cross-functional teams and third-partyvendors. Excellent communication, stakeholder management, and leadership skills. PMP/Prince2/CSM certification is a plus Good To Have Experience with data platforms, analytics in pharma, or AI/ML initiatives in life sciences. Exposure to cloud migrations, enterprise platformslike SAP, Veeva, Oracle Health Sciences, etc. Prior experience with global project rollouts across geographies. Understanding of pharma manufacturing processes, quality control, or clinical development lifecycle

Alembic Pharmaceuticals is seeking a LIMS LabWare Architect with strong expertise in the design, implementation, and maintenance of Laboratory Information Management Systems built on the LabWare platform . The ideal candidate will be responsible for translating laboratory requirements into effective technical solutions, overseeing system development, and integrating LIMS with other enterprise systems. Responsibilities: Configure and maintain Labware LIMS to meet laboratory requirements. Manage LIMS workflows, templates, and reports. Integrate Labware LIMS with other laboratory instruments and enterprise systems. Provide technical support and troubleshooting for LIMS-related issues. Collaborate with laboratory staff to gather user requirements and ensure system functionality aligns with their needs. Conduct training sessions for end-users on LIMS functionalities and best practices. Ensure compliance with regulatory standards and data integrity. Qualifications: Bachelor's degree in Computer Science, Information Technology, or related field. 8-10 years of experience working with Labware LIMS. Functional knowledge of laboratory processes and workflows. Technical skills in integrating LIMS with third-party tools and systems. Strong problem-solving and analytical skills. Excellent communication and interpersonal skills. Preferred Skills: Proficiency in SQL, scripting languages, and data management. Knowledge of regulatory requirements (e.g., GxP, FDA, ISO).Familiarity with laboratory instruments and their integration with LIMS. Interested candidate can share there profiles as "Itcv@alembic.co.in" with the subject line " LIMS LabWare Architect"

Job Details Strong skills in Core Java, J2EE, , JavaScript, JSP, and DHTML/Web Page development. Experience in Labvantage LIMS development Strong relational database knowledge and experience using either Oracle and/or SQL Server.

Role: Business Analyst cum Solution Designer Department : IT Location : Hyderabad About Us: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace diversity and follow equal opportunity practices across all levels. About the Role: We are looking for a highly analytical and domain-experienced Business Analyst cum Solution Designer to join our Discovery and PR&D IT team. The successful candidate will play a pivotal role in understanding scientific workflows, gathering business requirements, and designing effective digital solutions across platforms such encompassing the DMTA (DesignMake–Test–Analyze) cycle. This role demands hands-on experience in managing application lifecycles within discovery and development environments in the pharmaceutical industry. Key Responsibilities : Collaborate with discovery scientists, analytical chemists, and PR&D stakeholders to gather and translate business needs into functional requirements. Design end-to-end digital workflows that align with discovery and PR&D operational processes. Lead the implementation and optimization of the DMTA cycle, ensuring integration with compound registration, inventory, and analytical systems. Partner with internal IT teams and external vendors to ensure architecture, configuration, and customization of solutions meet scientific and business objectives. Prepare and manage user stories, functional specifications, and validation documentation including URS, FRS, IQ/OQ/PQ. Conduct system testing, coordinate User Acceptance Testing (UAT), and ensure adherence to 21 CFR Part 11, GxP, and data integrity guidelines. Drive change management initiatives, end-user training, and adoption strategies for new system features and workflows. Work with data and analytics teams to enable integration and visualization of scientific and operational data for enhanced decision-making. Following site quality procedures and maintain documentation wherever applicable. Performing POCs on new technologies required for organization. Coordinating and supporting Jr. Engineers at Unit for SIEM activities and guide around technical tools and process adherence. Experience/Qualification: B.Tech/MCA with 5-10 years of relevant industry experience. Key Competencies (Technical, Functional & Behavioural): 1. Good communication skills 2. Demonstrate ownership and collaboration at work

Responsible for the availability of raw materials, catalysts and instrument spares as per high pressure lab requirements. To analyse quality results and discuss the experimentation plan and parameters with Research Incharge. Understand the safety aspects of all reactions, chemicals and catalysts to be used in high pressure reactions. Ensure the proper setup ( compatability of autoclave, high pressure addition pumps, thermostats etc) as planned. Carry out reaction process as per the provided plan, get the analysis done for raw materials, catalysts , in process reaction intermediates and product. Record all observations and give suggestions for improvement. Report any breakdown, abnormal functioning of instruments in high pressure lab. Ensure proper housekeeping of the lab. Maintain highest safety practices while working by using required PPEs (Personal protective equipment). Maintain the log sheets of all the experiments regularly with critical observations and feed the data into Electronic Lab Notebook (ELN). Ensure working in lab as per SOP's provided. Maintain stock of all the chemicals, catalysts and instrument spares required as per 5'S' (sort, set-in-order, shine, standardize, sustain) After reaction completion, decontaminate the autoclave/instruments properly. To ensure proper and complete recovery/quenching of catalysts after reaction. To ensure proper and safe storage of catalysts and maintain its record. Segregate effluents as per the lab system. To undergo trainings as per schedule. Roles and Responsibilities Note:- Experience in High pressure Lab is must

Role & responsibilities Strong working experience in Revvity signals (Previously known as Perkin Elmer ELN) Strong working experience in template design, development, Protocol development, configurations and Instrument connectivity Delivery and design experience for pharma customers using Revvity signal Strong understanding of lab process, CSV and domain understanding Working experience in customer facing role

Key Deliverables: Configure and maintain Quality Control platforms including LIMS, ELN, and Empower CDS Develop and deploy application features to support QC operations with cloud and database integration Perform system administration, incident resolution, and ensure application availability Document, test, and debug code to maintain high-quality system performance Role Responsibilities: Collaborate with teams to design scalable, functional technical solutions Participate in code reviews, unit testing, and deployment for QC systems Support database modeling and integration across Oracle and MySQL environments Stay updated with emerging cloud and automation tools to enhance QC platforms

Mode of Work : Hybrid Location : Pune, Bangalore, Hyderabad, Pune, Noida, Gurgaon, Chennai, Kolkata, Skill Set : Computer System Validation (CSV ), Veeva Vault , Trackwise , Argus The opportunity Were looking for Senior with expertise in Computer System Validation and stakeholder management to join our Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach. Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement. Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements. Skills and attributes for success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills. Interested Candidates can send their cv's to frichardson@allegisglobalsolutions.com Looking for candidates from Pharma Companies. Regards, Franklin.A

Labware LIMS Functional consultant with experience in Labware LIMS, Labware ELN, Labware Mobile, LIMS V7, Implementation, rollouts, GXP, FDA, ISO,

Role Responsibilities: Develop and deploy code to support QC applications Document code and translate requirements into technical design Conduct unit/integration testing and debugging Provide application support, including incident and security management Key Deliverables: Fully functional Quality Control software modules Clear and complete documentation of code and changes Efficient incident response and system administration Validated deployment of features aligned with business needs

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. You will join a multi-functional team of scientists and software professionals enabling technology and data capabilities to evaluate drug candidates and assess their ability to affect drug targets. This includes implementing scientific software platforms like Laboratory Information Management Systems (LIMS) and Electronic Lab Notebooks (ELN), providing technical support, training, infrastructure management, and ensuring systems meet research needs. Key Responsibilities Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics and research scientists , prioritizing needs and expectations Manage a suite of custom internal platforms , COTS software , and systems integrations Lead the technology ecosystem for in vivo study data management , ensuring data analysis and data integrity Translate complex scientific and technological needs into clear, actionable development requirements Develop and maintain a product roadmap , including features, enhancements, timelines, and milestones Identify and manage risks including technological, scientific validation, and user acceptance Develop documentation, communication plans, and training for end users Ensure scientific data operations align with enterprise-wide AI/ML capabilities Ensure operational excellence, cybersecurity, and compliance Collaborate with geographically dispersed teams in the US and internationally 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 03 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field OR Diploma with 47 years of experience in the above fields Demonstrated expertise in a scientific domain area and related technology needs Excellent problem-solving skills with a passion for applying tech and data to drug discovery Experience writing user requirements and acceptance criteria in tools such as JIRA Experience with Benchling, Revvity, IDBS , or similar LIMS/ELN platforms Preferred Qualifications Experience with Agile methodologies (Scrum) Experience enabling data capture and analysis from lab or vivarium instruments Ability to translate technical concepts into business-friendly language Knowledge of business analysis practices , DevOps , CI/CD methodologies Experience with cloud infrastructure (e.g., AWS) and on-premise systems Experience supporting ELN/LIMS platforms in biopharma Professional Certifications (Preferred) SAFe for Teams certification Soft Skills Able to work with minimal supervision Strong analytical and gap/fit assessment skills Excellent verbal and written communication Ability to work effectively in global, virtual teams High degree of initiative and self-motivation Strong ability to manage multiple priorities Team-oriented with a focus on team success Strong presentation and public speaking skills

Roles & Responsibilities: 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 We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Masters degree and 1 to 3 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Bachelors degree and 3 to 5 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Diploma and 7 to 9 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field Preferred Qualifications: Experience in implementing and supporting biopharma scientific software platforms Functional Skills: Must-Have Skills: Proficient in a General Purpose High Level Language (e.g. Python, Java, 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) Good-to-Have Skills: 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 Benchling, Revvity, IDBS, or similar LIMS/ELN platforms Professional Certifications (please mention if the certification is preferred or mandatory for the role): 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

Job Title: LabWare ELN Specialist Experience: 4+ Years Location: Bangalore (BLR) Client: Merck Shift Timing: 1:30 PM to 10:30 PM IST Mode: Full-time Job Description: We are looking for a highly skilled LabWare ELN Specialist with a minimum of 4 years of hands-on experience in configuring, implementing, and supporting LabWare Electronic Lab Notebook (ELN) solutions. The ideal candidate will play a key role in managing and enhancing the LabWare ELN system to support R&D and laboratory workflows at our client site Merck, Bangalore . Key Responsibilities: Design, develop, and maintain workflows in LabWare ELN. Gather requirements from scientific and business users to translate into ELN solutions. Support ELN template creation, configuration, and integration with other lab systems. Troubleshoot and resolve ELN-related issues, ensuring minimal disruption. Collaborate with QA, LIMS, IT, and other stakeholders for validation and compliance needs. Maintain proper documentation and adhere to GxP/21 CFR Part 11 standards. Must-Have Skills: 4+ years of experience with LabWare ELN (Electronic Lab Notebook). Strong experience in ELN configuration and template development. Working knowledge of LabWare LIMS is a strong plus. Familiarity with scripting, SQL, or related programming for LabWare ELN customization. Knowledge of pharmaceutical or biotech laboratory workflows. Good understanding of GxP, 21 CFR Part 11 , and data integrity standards. Excellent communication skills and ability to interact with cross-functional team

What you will do In this vital role you will lead a team responsible for overseeing the organization's information technology strategy and execution. You will collaborate with key customers to identify business needs, develop technology roadmaps, handle IT projects, and ensure the delivery of high-quality solutions. Your leadership and strategic approach will enable you to drive innovation, optimize system performance, and enhance the overall IT capabilities to support the company's goals. You will play a pivotal role in advancing digital capabilities across Process Development and Manufacturing. Demonstrating state-of-the-art technologies, including Generative AI and Machine Learning, you will ensure the seamless flow of instrument data across operational business processes and applications enabling a unified data platform for robust, consistent, standardized data and analytics across the Amgen network. Additionally, you will help streamline the experience for Lab Scientists, Production Operators, Floor management, and Quality Assurance fostering Best-In-Class Process Innovation. You will lead a dynamic team of technical product owners, business analysts, test/validation engineers, project managers and scrum masters responsible for the digital roadmap strategy, ongoing design, development, management, and optimization of Amgen Operations Electronic Lab Notebook and Instrument Data Acquisition Platform. You will also be the reporting manager for this team and will be responsible for coaching and development of these resources Own, run, and support Operations Enterprise Lab Information Management solutions, including Biovias Holistic Lab ELN Platform. Provide lab systems roadmap for Amgen Operations, collaborating with IS Architects, Infrastructure Leads, and Business Analysts to develop roadmaps supporting organizational priorities and platform improvements. Lead implementation of digital lab initiatives, providing experiment design, authoring, and execution solutions. Align business processes with Holistic Lab, PLM, and Big Data technology capabilities by working with multi-functional representatives across Operations and sites. Guide project teams on developing approaches for addressing business needs and presenting arguments for proposed solutions, while supervising vendors and contractors to ensure deliverables. Maintain strategic relationships and good communication with the leadership team, ensuring all collaborators are informed and engaged. Oversee the software development lifecycle, ensuring best practices in development, testing, and deployment across product teams, and lead large, diverse teams within a matrixed organization. Develop and implement strategic plans for technology and workforce growth, including recruiting top talent and building a robust team in India, while fostering a culture of collaboration, innovation, and continuous improvement. Collaborate with Platform Owners, Product Owners, Service Owners, and delivery teams to ensure delivery matches commitments, acting as a critical issue point and facilitating communication when service commitments are unmet. Ensure overall organizational compliance with quality and GxP in technology services, monitor emerging technologies and trends for platform growth, and ensure ongoing alignment with strategy, compliance, and regulatory requirements. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The ideal candidate will have a consistent track record of leadership in technology-driven environments with a passion for fostering innovation and excellence in the biotechnology industry. The role requires strong expertise in ELN Applications, Enterprise Application Integration, end-to-end data and process harmonization, as well as handling the seamless integration of Lab Instrument data to various enterprise business applications. This individual will handle key vendors and partner with key customers orchestrating the implementation of solutions that enable next generation lab processes including simulations, machine learning and knowledge management. They should also have experience leading and effectively working with large, diverse and globally dispersed teams within a matrixed organization. Extensive collaboration with global multi-functional teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a good background in the end-to-end software development lifecycle, technical product ownership, business analysis, be a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational critical initiatives, develop a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Basic Qualifications: Doctorate Degree and 2 years of experience in Engineering, IT or related field OR Masters degree with 8 - 10 years of experience in Engineering, IT or related field OR Bachelors degree with 10 - 14 years of experience in Engineering, IT or related field OR Diploma with 14 - 18 years of experience in Engineering, IT or related field Background as a Technical Product Owner (TPO), people manager, and business analyst, ensuring the ability to supervise and guide a team to translate business needs into definition and delivery of technical solutions, guiding development teams, prioritizing features, and ultimate delivery and management of the digital products. Validated experience and involvement in Enterprise Projects targeted for process reliability of manufacturing and product life cycle as well as streamlining end-to-end data flow and agile execution of critical operational workflows. Proven leadership skills with the ability to lead large matrixed teams. In addition, demonstrable experience in leading and developing a hard-working team of technology professionals, building a culture of innovation and continuous improvement within the team to deliver powerful solutions and platform improvements. Experience in implementing a strategic roadmap and driving transformation initiatives using Scaled Agile methodology. Solid skills in collaborating and communicating with multi-functional teams, business collaborators, and executives to ensure alignment of platform initiatives with business outcomes, handling expectations, and ensuring successful delivery of projects. Degree in Computer Science, Information Systems, Engineering, or Life Sciences. Preferred Qualifications: At least 5-8 years of domain knowledge in health and/or life sciences combined with Information Technology Understanding and applied experience in Lab Informatics and multi-functional data harmonization Good overall understanding of business, manufacturing, and laboratory systems common in the process manufacturing as well as the integration of these systems through applicable standards Up-to-date knowledge of vendors software strategy, information of available challenging solutions and the ability to translate these to the changing business environment in PD such that we can continually improve software investments. Experience handling a globally distributed enterprise application platform Solid depth or breadth of expertise with offerings within the Lab solution landscape including ELN, inventory management, MES and scientific analysis tools Leadership experience within a highly regulated pharmaceutical or technology organization, with the ability to ensure compliance with industry regulations and standard methodologies for GxP software validation. Experience directing solution design, business processes redesign and software implementation in a drug development lab / commercialization environment Understanding of FDA regulations governing computer system validation and operation in biotech manufacturing and laboratory areas Strong analytic/critical-thinking and decision-making abilities. Demonstrated ability to work effectively in a fast-paced, dynamic environment. Extensive experience in the software development lifecycle. Experience using and adoption of Scaled Agile Framework (SAFe) Understanding of ITIL processes and implementation. Established business partnerships and IS governance practices involving senior business partners Experience handling vendor relationships and working with external partners or consultants to ensure optimal performance, support, and development of digital products. Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Ability to work effectively with global, virtual teams. Excellent analytical and troubleshooting skills. Ability to handle multiple priorities successfully. Strong presentation and public speaking skills. Strong verbal and written communication skills. High degree of initiative and self-motivation. Work Hours : 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.

Hi, We are having an opening for R&D-IT Manager-ELN at our Baroda location. Job Summary : R&D-IT Manager will be responsible for the successful implementation of assigned projects. This role requires a strong technical skills and deep compliance understanding of R&D and Lab procedures and processes and the ability to work closely with cross-functional teams to ensure IT applications are running successfully. Experience in ELN implementation is preferred. Role and Responsibilities : ELN implementation for R&D Functions NuGenesis SDMS platform upgrade implementation Implementation of PMS- Store Inventory & Equipment inventory Computer System Validation of scientific software and instrument software Managing and closure of assigned QMS within the timelines Application support for Regulatory information management project Implementation support, testing and documentation of ongoing projects at R&D Baroda site Responsible to face internal/external audits and draft audit response, as needed Qualifications and Preference Qualifications Bachelor's degree in Information Technology, or Computer Science or related field. Minimum of 5-7 years of experience in application support, preferably Pharma/ life sciences domain Ability to manage multiple tasks and projects simultaneously. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Preferred Qualifications Familiarity with laboratory instruments and software ELN implementation experience Good documentation skills to create and manage GxP documents Project Management skills

Role: Seeking a Product Owner with functional expertise in ELN platforms like Benchling . Should have experience working as a Business Analyst or Product Owner for ELN development or integration projects in Pharma or Life Sciences. Mandatory skillset- ELN Benchling Responsibilities: Define and manage the product vision, roadmap, and backlog for ELN solutions. Gather and prioritize requirements from R&D, lab users, and business stakeholders. Collaborate with technical teams to drive ELN development, customization, and integration. Ensure seamless interoperability of ELN with LIMS, CDS, SDMS, and other lab systems. Align ELN solutions with regulatory standards (GxP, ALCOA+) and industry best practices. Facilitate user adoption through training, documentation, and stakeholder engagement.

Job Title: Informatics Qualification Postgraduate in Science/MCA with a minimum of 10- 18 years of IT experience in the Pharmaceutical / Life science domain Technical Skills Experience in demonstrating a track record of delivering scientific solutions in the pharmaceutical and CRO industry. Experience in the implementation of Informatic applications like (Electronic Laboratory Notebooks(elNB), Laboratory Information Management System, Chromatography Data system (CDS) and other scientific applications. Experience with Software development life cycle (SDLC) and Computer System Validation (CSV). Should have experience in running projects with CSV life cycle. Candidate should have knowledge of current regulatory & Guidelines (GAMP5) for CSV, i.e. 21 CFR Part 11 ERES, Part 820, Part 210 & 211, EU Annex 11, ICHQ9 and SOP requirements of computerized systems w.r.t. data security, traceability and integrity. Candidate should be familiar with GCP, GLP and GMP guidelines/SOPs. The candidate should have skills in managing Regulatory & Client Audits (experience in supporting internal and external audits). Other Skills: Strong leadership, communication, consulting and influencing skills. Must have experience in resource management - channelizing resources to track current and future program resource assignments. Must have excellent team collaboration skills and the ability to lead and motivate cross-functional teams. Strong analytical and communication skills are required. Roles and Responsibilities: Responsible for supporting informatics applications of the assigned departments. In collaboration with the scientific community identify, evaluate and implement software applications meeting business requirements. Implement new projects/solutions as per business needs. Coordinates between scientists and vendors for any solution development/implementation Ensure effective utilization of scientific systems and applications Coordinate with Syngene clients and/or vendors to roll out scientific applications extended to Syngene Facilitate computer system validation and ensures that scientific applications are GxP compliant as per the operating unit requirements Responsible for ensuring 21 CFR Part 11 compliance for enterprise & standalone applications Focus on near-zero downtime for enterprise applications Technical support and administration of scientific and associated applications. Challenges / error handling, escalation and troubleshooting of scientific and associated applications. Responsible for effective coordination among clients, operating unit and internal IT team for the application / infrastructure challenges faced by the operating unit to minimize or eradicate the downtime Responsible to provide the right solution for the challenges faced by the operating units Responsible for implementation / suggestion of any IT related process improvements for the operating units Location: Bangalore

Role: Seeking a Product Owner with functional expertise in ELN platforms like Benchling, iLab, and Biovia. Should have experience working as a Business Analyst or Product Owner for ELN development or integration projects in Pharma or Life Sciences. Responsibilities: Define and manage the product vision, roadmap, and backlog for ELN solutions. Gather and prioritize requirements from R&D, lab users, and business stakeholders. Collaborate with technical teams to drive ELN development, customization, and integration. Ensure seamless interoperability of ELN with LIMS, CDS, SDMS, and other lab systems. Align ELN solutions with regulatory standards (GxP, ALCOA+) and industry best practices. Facilitate user adoption through training, documentation, and stakeholder engagement.