3536 Oncology Jobs - Page 23

Let s do this. Let s change the world. In this vital role you will maximise 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 role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. 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 collaborate with Product Managers and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. Roles & Responsibilities: Collaborate with System Architects and Product Managers to manage business analysis activities, ensuring alignment with engineering and product goals. Capture the voice of the customer to define business processes and product needs. Work with Product Managers and customers to define scope and value for new developments. Collaborate with Engineering and Product Management to prioritize release scopes and refine the Product backlog. Ensure non-functional requirements are included and prioritized in the Product and Release Backlogs. Facilitate the 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 customers understand how they fit into the product backlog. Ensure Acceptance Criteria and Definition of Done are well-defined. Work closely with UX to align technical requirements, scenarios, and business process maps with User Experience designs. Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators. Develop and implement effective product demonstrations for internal and external collaborators. Maintain accurate documentation of configurations, processes, and changes. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree and 3 to 5 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma and 7 to 9 years of Life Science / Biotechnology / Pharmacology / Information Systems experience. Functional Skills: Must-Have Skills: Excellent problem-solving skills and a passion for tackling complex challenges in clinical development with technology Experience with Agile software development methodologies (Scrum) Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity Experience in writing requirements for development of modern web application Has experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Good-to-Have Skills: Demonstrated expertise in a clinical domain area and related technology needs. Understanding of software systems strategy, governance, and infrastructure. Experience in managing product features for PI planning and developing product roadmaps and user journeys. Familiarity with low-code, no-code test automation software. Able to communicate technical or complex subject matters in business terms Jira Align experience. Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology. Knowledge of cloud platforms (AWS, Azure, GCP). 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.

Let s do this. Let s change the world. In this vital role you will be responsible for 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 role involves working closely with Veeva - Vault CTMS business customers, Veeva engineers, data engineers, AI/ML engineers to ensure that the technical requirements for upcoming development are thoroughly elaborated. 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 collaborate with Product Managers and developers to maintain an efficient and consistent process, ensuring quality work from the team. Roles & Responsibilities: Collaborate with System Architects and Product Managers to manage business analysis activities for Veeva - Vault CTMS system, ensuring alignment with engineering and product goals. Capture the voice of the customer to define business processes and product needs. Work with Product Managers and customers to define scope and value for new developments. Collaborate with Veeva - Vault CTMS business collaborators, Amgen Engineering teams and Veeva consultants to prioritize release scopes and refine the Product backlog . Support the implementation and integrations of Veeva - Vault CTMS with other Amgen systems. Ensure non-functional requirements are included and prioritized in the Product and Release Backlogs. Facilitate the 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. Work closely with UX to align technical requirements, scenarios, and business process maps with User Experience designs. Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators. Develop and implement effective product demonstrations for internal and external customers. Maintain accurate documentation of configurations, processes, and changes. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree and 3 to 5 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma and 7 to 9 years of Life Science / Biotechnology / Pharmacology / Information Systems experience Preferred Qualifications: Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology. Experience with Agile software development methodologies (Scrum). Good communication skills and the ability to collaborate with senior leadership with confidence and clarity. Experience in writing requirements for development of modern web application. Has experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA. Good-to-Have Skills: Familiarity with Veeva Clinical Platform, especially Veeva - Vault CTMS system . Experience in managing product features for PI planning and developing product roadmaps and user journeys. Technical thought leadership. Able to communicate technical or complex subject matters in business terms. Experience of DevOps, Continuous Integration, and Continuous Delivery methodology. SAFe for Teams certification (preferred). Certifications in Veeva products (Preferred). Certified Business Analysis Professional (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. 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.

Let s do this. Let s change the world. The Senior Associate position offers a unique opportunity to join a fun, innovative engineering team within the Enterprise Data Strategy and Engineering (EDSE) organization. You ll work on building next-generation capabilities and services in Data and AI using innovative open-source software, frameworks, tools, and cloud computing services. The role also emphasizes demonstrating these capabilities to support critical business operations and initiatives, ensuring alignment with organizational priorities. As a senior associate, for business performance, you will monitor departments performance looking at various projects, initiative and ongoing work to track and report the insights and updates. You will get connected with different teams: engineering, product, project management etc. to understand and report the performance. Analyze business performance data to identify trends, variances, and improvement opportunities. Collaborate with stakeholders to define and refine Key Performance Indicators (KPIs). Develop and maintain dashboards and reports using tools like Power BI, Tableau, or similar. Conduct ad-hoc and deep-dive analyses to support strategic initiatives and operational decisions. Present findings and recommendations to senior leadership in a clear and compelling manner. Support the execution of business performance strategies. Stay updated on industry trends, tools, and best practices in data analytics and business intelligence to track business performance. Provide updates and insights in best possible presentable format for the leadership and other teams. What we expect of you Master s degree and 4 to 6 years of business performance experience OR Bachelor s degree and 6 to 8 years of Information Systems experience OR Diploma and 8 to 11 years of Information Systems experience At least 4 years of relevant experience in a business performance role. Basic Qualifications: Understanding of different KPIs/metrics (operational, projects and financials) and ability to track, monitor and report those. Good analytical skills. Proficiency with data tools (e.g. excel, power bi, Tableau etc) Experience in communication and presentation to leadership. Excellent stakeholder management skills. Excellent communication and social skills, with the ability to work collaboratively with different teams. Preferred Qualifications: Ability to work effectively across matrixed organizations and lead in collaboration. Passion for technology and customer success, particularly in driving innovative AI and data solutions. Familiarity with biotech/pharma is beneficial. Soft Skills: Excellent analytical and solving skills. Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to handle 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.

Let s do this. Let s change the world. In this vital role you will conduct complex complaint investigations, resolves corrective actions with their effectiveness and resolves steps necessary to ensure the proper level of control for product in distribution. We are seeking a Specialist Quality Complaints Complaint Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. Ensures quality of complaint records Applies analytical abilities to evaluate complex situations using multiple sources of information Execution of regulatory and SOP requirements Anticipates and prevents potential issues with regulators Provides guidance and technical advice Evaluates subject matter expert assessments Raises potential Quality issues to Management What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR , Master s degree and 4 to 6 years of Specialist Quality Complaints experience OR , Bachelor s degree and 6 to 8 years of Specialist Quality Complaints experience OR , Diploma and 10 to 12 years of Specialist Quality Complaints experience Preferred Qualifications: Quality and manufacturing experience in biotech or pharmaceutical industry Ability to oversee multiple projects simultaneously Ability to successfully handle workload to timelines Familiarity with basic project management tools Ability to negotiate a position after taking feedback from multiple sources Demonstrated ability to consistently deliver on-time, and high-quality results Ability to operate in a matrixed or team environment Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) 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.

Let s do this. Let s change the world. In this vital role you will be responsible for the development and maintenance of software in support of target/biomarker discovery at Amgen. The IS Architect designs the supporting infrastructure (servers, network, storage, etc.) for scalability, reliability, manageability, performance, and security per solution needs ensuring adherence to enterprise standards and patterns. Proper design of the infrastructure environment aligned to the needs of the solution promotes stability, scalability, and effective operation of the supported systems. Furthermore, by adhering to enterprise standards, solution delivery is accelerated and cost reduction realized while gaining additional benefits from a known platform that can be maintained and monitored. Roles & Responsibilities: Develop infrastructure reference models, standards, and patterns to guide and govern IS project delivery. Develop the enterprise infrastructure target state architecture aligned with Amgen s strategic goals. Develop infrastructure roadmaps detailing initiatives and landmarks to meet the target state architecture. Assist with identifying, developing, and leading innovation initiatives including proof-of-concept exploration. Participate in architecture reviews to provide governance over the use of infrastructure assets. Partner closely with LFA role to drive enterprise adoption of architecture standard processes. Promotes the use of a shared infrastructure roadmap to reduce costs and improve how information flows. 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: Bachelor s / Master s degree with 8 - 13 years of experience in IS Architecture, or related field. Preferred Qualifications: 2+ years of experience in biopharma or life sciences. Must-Have Skills: Proven experience in cloud computing (AWS) and cloud architecture (AWS Batch, AWS HealthOmics, AWS PCluster, etc...) Proficiency in scripting languages (Python, Bash) and containerization technologies (Docker, Kubernetes). Experience with infrastructure as code (IaC) tools (i.e. Terraform, CloudFormation, Ansible) Knowledge of networking, security, and database technologies in a cloud environment. Experience with HPC systems Good-to-Have Skills: Experience with job schedulers (like SLURM, PBS), resource management, and system monitoring tools (DynaTrace). Ability to troubleshoot common issues with HPC systems Solid Understanding of Linux/Unix operating systems (RHEL/Ubuntu) Excellent problem-solving, communication, and team collaboration skills. Proficiency with virtual compute environments (EC2). Strong background in AI/ML technologies, with experience in deploying ML models. Familiarity with machine learning frameworks (TensorFlow, PyTorch) and data pipelines. Certifications in cloud architecture (AWS Certified Solutions Architect, Google Cloud Professional Cloud Architect, etc.). Experience in an Agile development environment. Prior work with distributed computing and big data technologies (Hadoop, Spark). Operational experience running large scale platforms, including AI/ML platforms and AI 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.

Let s do this. Let s change the world. In this vital role you will support the delivery of emerging AI/ML capabilities within Amgens Neural Nexus program. As part of the Commercial Technology Data & Analytics team, you will collaborate with product owners and cross-functional partners to help design, implement, and iterate on a layered ecosystem passionate about DIAL (Data, Insights, Action, and Learning). Collaborate with the Commercial Data & Analytics (CD&A) team to help realize business value through the application of commercial data and emerging AI/ML technologies. Support delivery activities within the Scaled Agile Framework (SAFe), partnering with Engineering and Product Management to shape roadmaps, prioritize releases, and maintain a refined product backlog. Contribute to backlog management by helping break down Epics into Features and Sprint-ready User Stories, ensuring clear articulation of requirements and well-defined Acceptance Criteria and Definitions of Done. Ensure non-functional requirements are represented and prioritized within the backlog to maintain performance, scalability, and compliance standards. Collaborate with UX to align technical requirements, business processes, and scenarios with user-centered design. Assist in the development and delivery of engaging product demonstrations for internal and external partners. Support documentation efforts to maintain accurate records of system configurations, processes, and enhancements. Contribute to the launch and growth of Neural Nexus product teams focused on data connectivity, predictive modeling, and fast-cycle value delivery for commercial teams. Provide input for governance discussions and help prepare materials to support executive alignment on technology strategy and investment. What we expect of you We are all different, yet we all use our unique contributions to serve patients. We are seeking a highly skilled and experienced Specialist IS Business Analyst with a passion for innovation and a collaborative working style that partners effectively with business and technology leaders with these qualifications. Basic Qualifications: Doctorate degree / Masters degree / Bachelors degree with 8 to 13 years of experience in Information Systems Experience with writing user requirements and acceptance criteria Affinity to work in a DevOps environment and Agile mind set Ability to work in a team environment, effectively interacting with others Ability to meet deadlines and schedules and be accountable Must-Have Skills Excellent problem-solving skills and a passion for solving complex challenges in for AI-driven technologies Experience with Agile software development methodologies (Scrum) Superb communication skills and the ability to work with senior leadership with confidence and clarity Has experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience in managing product features for PI planning and developing product roadmaps and user journeys Good-to-Have Skills: Demonstrated expertise in data and analytics and related technology concepts Understanding of data and analytics software systems strategy, governance, and infrastructure Familiarity with low-code, no-code test automation software Technical thought leadership Able to communicate technical or complex subject matters in business terms Jira Align experience Experience of DevOps, Continuous Integration, and Continuous Delivery methodology Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Technical Skills: Experience with cloud-based data technologies (e.g., Databricks, Redshift, S3 buckets) AWS (similar cloud-based platforms) Experience with design patterns, data structures, test-driven development Knowledge of NLP techniques for text analysis and sentiment analysis 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.

Specialist IS Engineer for GEN AI solutions across various Process Development functions(Drug Substance, Drug Product, Attribute Sciences & Combination Products) in Operations functions is responsible for building cutting edge GEN AI solutions. The role involves working closely with Data Scientists developing, implementing and sustaining GEN AI solutions to help find relevant, actionable information quickly and accurately. Roles & Responsibilities: Possesses strong rapid prototyping skills and can quickly translate concepts into working code 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 teams, business team, and other key partners. Design, develop, and deploy applications that use LLMs like OpenAI GPT Build and maintain MLOps pipelines, including data ingestion, chunking, vectorization, feature engineering, model training, deployment, and monitoring Design, fine-tuning, and optimization of state-of-the-art LLMs for various applications, focusing on both performance and accuracy Implement DevOps/MLOps/LLMOps standard methodologies to automate ML workflows and improve efficiency. Develop and implement monitoring systems to track model performance and identify issues. Conduct testing and experimentation to optimize model performance. Review code and maintain strong standards and practices on the team Work closely with data scientists, engineers, and product teams to deliver ML solutions. Stay updated with the latest trends and advancements What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate Degree OR Master s degree with 4 - 6 years of experience in Software Engineering, Data Science or Machine Learning Engineering OR Bachelor s degree with 6 - 8 years of experience in I Software Engineering, Data Science or Machine Learning Engineering OR Diploma with 10 - 12 years of experience in Software Engineering, Data Science or Machine Learning Engineering Great foundation in machine learning algorithms and techniques Must-Have Skills: Expertise in Python and relevant ML libraries (e.g., Langchain, TensorFlow, PyTorch) Experienced with software engineering best-practices, including but not limited to version control (Git, Subversion, etc.), CI/CD (Jenkins, Maven etc.), automated unit testing, and Dev Ops Excellent problem-solving skills and the ability to work with large, complex datasets. Experience in implementing Retrieval-Augmented Generation (RAG) pipelines, integrating retrieval mechanisms with language models. Experience in processing and leveraging unstructured data for GenAI applications Proven experience working with large language models (e.g., OPEN AI, LLAMA.). Experience in building, testing, and deploying machine learning models, particularly large language models, troubleshoot and optimize models. Experience in using cloud platforms (AWS, GCP, Azure) for ML model development, training, and deployment Preferred Qualifications: Solid understanding of Machine Learning (ML) workflows including ingesting, analyzing, transforming data and evaluating results to make meaningful predictions. Design, test, and deploy machine learning models, including LLMs, and develop scalable pipelines for both batch and real-time use cases. Professional Certifications: Machine Learning Certification (preferred on Databricks or Cloud environments). SAFe for Teams certification (preferred). Soft Skills: Excellent analytical and troubleshooting 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 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. Equal opportunity statement

Let s do this. Let s change the world. In this vital role you will responsible for managing complex Windows server environments. The role includes planning, implementation, performance tuning, and maintenance of enterprise server platforms with a focus on reliability, security, and automation. The ideal candidate will have a proven track record in Linux Server Operations and have a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with multi-functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in Linux server support and automation, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational strategic initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Please note, this is an on-site role based in Hyderabad. Roles & Responsibilities: Lead and develop a high-performing team managing Linux Server Develop and maintain server security and compliance standards Contribute to infrastructure design and architecture planning Implement automation using PowerShell, Python, or Ansible Monitor systems and proactively address performance bottlenecks Collaborate with multi-functional teams on infrastructure needs Document system configurations and operational procedures What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 6 + years of related field experience OR Bachelor s degree and 8+ years of related field experience OR Diploma and 12+ years of related field experience Advanced knowledge of Linux server operating systems (RHEL, Ubuntu and Amazon Linux) Experience with virtualization (VMware, Acropolis) Strong understanding of networking and storage integration Hands-on expertise in scripting and automation tools Preferred Qualifications: Experience with cloud services (AWS, Azure, GCP) Experience with ITIL processes and frameworks Experience with CI/CD and DevOps practices Understanding of configuration management and automation tools (Red Hat Satellite Server, Ansible) Professional Certifications: Red Hat Certified Engineer (RHCE) (preferred) ITIL Foundation (preferred) Soft Skills: Excellent troubleshooting and analytical abilities Strong communication skills, both written and verbal Ability to work in a fast-paced environment Strong organizational and time management skills Problem-solving and critical thinking capabilities Team collaboration and knowledge sharing Adaptability to changing priorities and technologies Ability to follow procedures accurately Willingness to learn and grow Shift Information: This position requires you to be onsite and participate in 24/5 and weekend on call in rotation fashion and may require you to work a later shift. Candidates must be willing and able to work off hours, as required based on business requirements. 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.

Let s do this. Let s change the world. In this vital role you will play a key role on the team supporting Finance process and technology requirements for Amgen s Financial Planning & Analysis (FP&A) organization. The Specialist IS Architect will report to the Director Finance based at Amgen s Capability Center in Tampa, FL. The Specialist IS Architect will be part of a team that will be responsible for supporting Amgen s FP&A organization by: Overseeing annual budget / LRP and quarterly forecast processes to ensure the system process is well planned, supported and executed Driving data quality and integrity in Anaplan and the Hyperion Financial Planning and Reporting system; understanding the data relationships and data flows between various systems including SAP, DRM, Anaplan and Hyperion Planning. Developing and executing plans to analyze, identify, test and re solve operational issues Collaborating effectively and actively with key business partners to identify and implement continuous process and system improvements to drive business initiatives Supporting system training programs and conducting training sessions to global business users What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications. Basic Qualifications: Doctorate degree Or Master s degree and 2 years of Information Systems and / or Finance experience Or Bachelor s degree and 4 years of Information Systems and / or Finance experience Or Associate s degree and 10 years of Information Systems and / or Finance experience Or High school diploma / GED and 12 years of Information Systems and / or Finance experience Preferred Qualifications: Experience in using and / or supporting Anaplan and Oracle Hyperion Planning (HP) and Data Relationship Management (DRM) Experience with Smartview Queries over Essbase Bachelor s degree in one or more of the following: Finance, Accounting, Computer Science, Finance Management Information Systems 2+ years experience in functional knowledge of financial budgeting and reporting processes in large company environment Experience with financial reporting, metrics and key finance performance indicators Strong organizational skills and ability to work with technical (IT) and Finance teams Ability to build and maintain relationships across various levels and functions Ability to manage change and process improvements effectively Ability to work effectively in teams Candidate should have strong analytical skills, as well as good interpersonal and communication (written and oral) skills Strong computer literacy and the ability to learn new applications readily 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.

Let s do this. Let s change the world. In this vital role you will contribute to Amgen s pipeline of new molecules and commercial products, that are treating serious illnesses and transforming lives. The Specialist CMC Statistician will be a member of our Global CMC Statistics (GCS) team. The mission of the team is to design, develop, and promote best practices, processes and tools across Operations that drive consistency and improve compliance. As part of the GCS team, the Specialist CMC Statistician will work with members of the team to implement statistical tools and techniques to support product manufacturing and testing throughout the product life cycle. The statistician will provide support to clinical and commercial manufacturing sites in the network. This involves statistical support for analyzing Operations generated data including monitoring programs, analytical methods, investigations, and other ad-hoc analyses as required. The Specialist CMC statistician will also support development of delivery devices and systems, and provide statistical analysis, study designs, acceptance sampling plans and acceptance criteria for the development, qualification, and transfer of physical test methods. They will also establish appropriate study designs and carry out evaluation of acceptance criteria for Design Verification testing ensuring that the overall program is aligned with Amgen and Regulatory/ISO requirements. Finally, the candidate will contribute to continuous improvement efforts across Amgen s networks, leading to harmonization, efficiency gains and scientific innovation and, administration of statistical training for Amgen s engineers and scientists. Primary Responsibilities for the Specialist CMC Statistician include: Provides continuous statistical support to a site or functional group by collaborating with technical associates to develop an experimental study, perform statistical analysis, and document results in a technical report that aligns with Amgen s document control system and has statistical integrity. Provides written responses to clarify and/or explain a statistical approach and performs additional analysis to support regulatory submissions and response to questions, as required. Participates in the development, implementation and maintenance of statistical tools used to support product life cycle activities assisting with drafting/updating white papers, writing standardized R and SAS code, outlining report templates, and aligning GCS duties in relevant SOPs. Participates in improvement efforts to promote statistical techniques used in biologics and monoclonal antibodies processes; and mentors and guides statistical techniques and software tools to technical associates. Stays up to date on biotechnology industry trends, best practices, guidance documents and participates in external conferences, as appropriate What we expect of you We are all different, yet we all use our unique contributions to serve patients. The highly motivated professional we seek is a collaborate partner with these qualifications. Basic Qualifications: Doctorate degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics or Master s degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics and 3 years of experience or Bachelors degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics and 5 years of experience or Associates degree and 10 years of experience Preferred Qualifications: Advanced degree in Applied or Industrial Statistics with 3 years experience applying statistical methodologies to support Biopharma manufacturing and control Proficient in statistical tools and techniques commonly used in biopharma manufacturing and testing operations, such as Design of Experiments, Statistical Process Control, Process Capability Analysis, Measurement System Analysis, Acceptance Sampling Plans, Non-linear and Linear Regression, Significance Tests, and Simulation. Proficient in SAS and/or R programming (data manipulation techniques, macro, statistical and graphical PROCS, and ODS) and JMP statistical software Excellent interpersonal, oral and written communication 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.

Let s do this. Let s change the world. In this vital role you will responsible for developing and maintaining the overall IT architecture of the organization. In this role you will be responsible for designing and implementing information system architectures to support business needs. You will analyze requirements, develop architectural designs, evaluate technology solutions, and ensure alignment with industry best practices and standards. You will be working closely with collaborators to understand requirements, develop architectural blueprints, and ensure that solutions are scalable, secure, and aligned with enterprise standards. Architects will be involved in defining the enterprise architecture strategy, guiding technology decisions, and ensuring that all IT projects adhere to established architectural principles. Roles & Responsibilities: Develop and maintain the enterprise architecture vision and strategy, ensuring alignment with business objectives for Corporate Functions data architecture. Collaborating closely with business clients and key collaborators to align solutions with strategic objectives. Create and maintain architectural roadmaps that guide the evolution of IT systems and capabilities for Corporate Functions data architecture Establish and enforce architectural standards, policies, and governance frameworks Evaluate emerging technologies and assess their potential impact on the solution architecture Identify and mitigate architectural risks, ensuring that IT systems are scalable, secure, and resilient Maintain comprehensive documentation of the architecture, including principles, standards, and models Drive continuous improvement in the architecture by finding opportunities for innovation and efficiency Work with partners to gather and analyze requirements, ensuring that solutions meet both business and technical needs Ensure seamless integration between systems and platforms, both within the organization and with external partners Design systems that can scale to meet growing business needs and performance demands Deliver high-quality Salesforce solutions using LWC, Apex, Flows and other Salesforce technologies. Ensure alignment to established standard methodologies and definitions of done, maintaining high-quality standards in work Create architectural design and data model as per business requirements and Salesforce standard methodologies Proactively identify technical debt and collaborate with the Principal Architect and Product Owner to prioritize and address it effectively Negotiate solutions to complex problems with both the product teams and third-party service providers Build relationships and work with product teams; contribute to broader goals and growth beyond the scope of a single or your current project What we expect of you We are all different, yet we all use our unique contributions to serve patients. Doctorate degree / Masters degree / Bachelors degree and 8 to 13 years of Computer Science, IT or related field experience Preferred Qualifications: Strong architectural design and modeling skills Proficiency in Salesforce Health Cloud / Service Cloud implementation for a Call Center Solid hands-on experience of implementing Salesforce Configurations, Apex, LWC and integrations Solid understanding of declarative tools like Flows and Process Builder Proficiency in using Salesforce tools such as Data Loader, Salesforce Inspector to query, manipulate and export data Experience in developing differentiated and deliverable solutions Ability to analyze client requirements and translate them into solutions Ability to train and guide junior developers in standard methodologies Familiarity with Agile practices such as User Story Creation and, sprint planning Experience creating proofs of concept (PoCs) to validate new ideas or backlog items. Professional Certifications: Salesforce Admin Salesforce Advanced Administrator Salesforce Platform Developer 1 (Mandatory) Salesforce Platform Developer 2 Platform Builder Salesforce Application Architect Salesforce Health Cloud Accredited Professional (Preferred) Soft Skills: Excellent critical-thinking and problem-solving skills Good communication and collaboration skills Demonstrated awareness of how to function in a team setting Demonstrated awareness of presentation 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.

Let s do this. Let s change the world. In this vital role the Specialist Data Security Engineer covering Data Loss Prevention (DLP) and Cloud Access Security Broker (CASB) technologies. This role will report to the Manager, Data Security. This position will provide essential services that enable us to better pursue our mission. Specialist Data Security Engineers operate, manage, and improve Amgen s DLP and Cloud Access Security Broker (CASB) solutions. In our Data Security team, they will identify emerging risks related to changes in cloud technologies, advise management, and develop technical remediations to address those risks. Specialists lead the development of processes and procedures for multiple solutions which enable business units to remediate identify cloud data exposures. They run multiple projects simultaneously to implement and improve the cloud data security protection and use advanced analytics to demonstrate success. This engineer will play a key role in educating and evangelizing to technologists and business leaders the security strategies that both protect and enable business processes related to cloud data handling. Roles & Responsibilities: Designs, operates, maintains, and enhances capabilities for the technical systems that ensure protection of data for all Amgen global operations. Identifies new risk areas for data and plans controls to mitigate those risks. Researches new technologies, processes, and approaches based on industry practices and recommends future plans for data protection. Authors procedures and guidelines and advises on policies related to data protection requirements and remediation or investigation of violations. Develops and conducts training on data protection technologies for operations staff. Educates business leadership about data risk. Advises other technology groups on data protection strategies and recommends appropriate points of both technical and process integration. Partners with the Manager of Data Security to liaise to legal and human resources leadership on violation remediations. Collaborates with cloud strategy leaders and business unit leadership to ensure that cloud data protection is incorporated by design into new business projects. Collaborates with Cloud Security Engineers to integrate cloud data protection technology into the operations of traditional Data Loss Prevention operations. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 4 to 6 years of experience OR Bachelor s degree and 6 to 8 years of experience OR Diploma and 10 to 12 years of experience. Functional Skills: Must-Have Skills Familiarity with one or more security frameworks, especially in regulated environments. Proficiency specifying requirements for technical systems, as well as designing, implementing, and operating those systems. Expertise in global IT operations, including an understanding of regulatory and cultural differences encountered when dealing with international peers and customers. Demonstrated competence maintaining applications on Windows and Linux based operating systems, and basic understanding of one or more programming or scripting languages. Demonstrated proficiency with one or more Cloud Access Security Platforms (Elastica, Netskope, SkyHigh,etc) Track record of project management leadership, preferably using Agile methodology. Deep knowledge of the principles of Data Protection, including availability, integrity, and confidentiality of data. Good-to-Have Skills: Proficiency with communications focused on both the development of written technical processes and the ability to convey complex ideas clearly in front of an audience. Experience with data analytics focused on building executive reports Reputation of successfully navigating large enterprise environments, understanding both ITIL driven processes and business relationship building Ability to self-direct work on multiple priorities with little to no oversight, based on critical initiatives. Professional Certifications (please mention if the certification is preferred or required for the role): Systems Security Certified Practitioner (SSCP) or Security+ SANS Certifications Cloud security certifications Relevant vendor-specific certifications Soft Skills: Established analytical and gap/fit assessment 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 Effective 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.

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.

Let s do this. Let s change the world. In this vital role you will be a skilled Software quality & Validation lead to oversee and handle validation activities for data platforms and custom-built solutions. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and align with Amgen s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. This is a hands-on, growth-oriented position ideal for someone looking to deepen their skills in Front-end testing, Back-end testing, API testing, and test automation. You will play a key validation role in a regulatory submission content automation initiative which will modernize and digitize the regulatory submission process, positioning Amgen as a leader in regulatory innovation. The initiative leverages state-of-the-art technologies, including Generative AI, content management, and integrated data to automate the creation, and management of regulatory content. Roles & Responsibilities: Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications. Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Contribute to test automation scripting, framework maintenance, and CI/CD integration. Implement automated test suites across various layers including data pipelines, APIs, and semantic layers. Analyze test automation results, identify failures or inconsistencies, and assist in root cause analysis. Collaborate with multi-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines. Supervise the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. Find opportunities for process improvements in validation activities. Stay ahead of on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. 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: Master s degree with 4-6 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree with 6 - 8 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma with 10 - 12 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience Preferred Qualifications: Must-Have Skills: 5+ years of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 8-10 Years overall experience in Testing & Validation Projects 3 to 5 years overall experience in QA & Test Automation is expected. Experience leading software validation projects. Proficiency in developing and implementing validation protocols (IQ, OQ, PQ), reports, and related documentation. Hands-on experience implementing and analyzing automated test suites Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Good-to-Have Skills: Experience with automated and computer-controlled systems validation (21 CFR Part 11) Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to handle multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Ability to learn quickly, be organized and detail oriented. 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.

Let s do this. Let s change the world. The Veeva Vault Release Manager will spearhead Veeva change and release management initiatives within Amgen s Veeva Vault ecosystem. This role focuses primarily on change and release management, encompassing the planning, scheduling, and deployment of changes and releases across various Veeva Vault in Amgen. As the key point of contact, you will provide essential support and expertise to business key users. Roles & Responsibilities : Develop and implement the release management process for Amgen Veeva Vault paltform. Publish integrated release calendar; manage cut-over and rollback. Manage release plans, including timelines, resources, and risk assessments. Collaborate with IT and business teams to facilitate smooth and efficient Veeva releases. Assess and plan for the impact of Veeva changes and releases on collaborators. Develop and manage communication plans to engage Veeva collaborators and provide clear messaging. Identify and involve key collaborators and leaders, facilitating workshops and training to support change. Design and deliver training programs, offering ongoing support and coaching. Evaluate the impact of changes, address risks and resistance, and track the effectiveness of change efforts. Maintain documentation, prepare reports for senior management, and implement the best practices. Oversee planning, scheduling, and coordination of Veeva releases, ensuring alignment with change management strategies. Lead talent engagement and team-building activities to foster a positive work environment. Organize and manage internal communications, including monthly newsletters, to keep the collaborator informed and engaged. 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 8 - 10 years of experience in Business, Engineering, IT or related field OR Bachelor s degree with 10 - 14 years of experience in Business, Engineering, IT or related field OR Diploma with 14 - 18 years of experience in Business, Engineering, IT or related field Strong understanding of Veeva s Vault and its modules\applications. Proven ability to develop and implement change management strategies and communication plans. Strong experience in collaborator engagement, training, and change impact assessment. Experience in managing the release management lifecycle, including scheduling and coordination. 6-8 year Global Pharmaceutical experience. Team\People management experience. Experienced in GxP process. Experience working in agile methodology, including Product Teams and Product Development models. Proficiency in designing scalable, secure, and cost-effective solutions. Excellent written and verbal communication skills Preferred Qualifications: Familiarity with Agile methodologies for change management. Experience with change management tools and software. Knowledge of industry-specific regulations and standard methodologies, particularly in Life Sciences or Pharmaceuticals. Strong solution design and problem-solving skills Strong understanding of technology, function, or platform Ability to analyze client requirements and translate them into solutions Knowledge of Platform and Data Governance Professional Certifications Veeva Vault Platform Administrator (Mandatory) SAFe - DevOps Practitioner (Mandatory) SAFe for teams (Preferred) Soft Skills: Should be able convert business requirements into technical requirements Excellent critical-thinking and problem-solving skills Strong communication and collaboration skills Demonstrated awareness of how to function in a team setting Demonstrated awareness of presentation 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. 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.

Let s do this. Let s change the world. In this vital role you will responsible for leading and charting the course for the Research Informatics Biological Studies team that enables technology and data capabilities for Amgen Research to evaluate drug candidates and assess their abilities to affect the biology of drug targets. The role will provide leadership to the team that implements software platforms that enable 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 highly talented 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 biopharma scientific domains as well as informatics solution delivery with a proven track 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 and Managers, coupled with leadership and transformation 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. Collaborate with geographically dispersed teams, including those in the US, EU, and other international locations. Provide technology delivery leadership and domain expertise for Biological Studies product teams that enable in silico, in vitro and in vivo experimentation. Partner with Research and Technology leaders to create technology delivery strategy and prioritized agenda for Biological Studies. Provide leadership for the implementation and support of specialized technology platforms that enable streamlined and automated scientific data management ensuring data integrity from lab to analytics. Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities. Follow global standards and practices. Foster a culture of collaboration, innovation, and continuous improvement. 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 Amgen Technology team in India, ensuring global ways of working are embedded in the local organization. Understand the decision-making process, workflows, and business and information needs of business partners and collaborators. Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as a partner concern point and 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. Facilitate standard methodology sharing, ensuring ongoing alignment with the Technology & Digital strategy. Oversee operating budgets and product team budgets, ensuring regular review of actuals and latest estimates, managing according to agreed governance. Ensure alignment of Technology service plans across organization. Provide education to new partners with regards to Technology service offerings. Remain accountable for ensuring overall organizational compliance to quality/compliance requirements such as GXP and Privacy. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 8 to 10 years of Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR OR Bachelor s degree and 10 to 14 years of [Job Code s DisciLife Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Diploma and 14 to 18 years of 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 Experience performing or enabling data capture and analysis from instruments in a research laboratory or vivarium Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data Demonstrated experience building strong teams with consistent practices in a matrix organization Preferred Qualifications: 6+ years of experience in implementing and supporting biopharma scientific software platforms. Experience in a leadership role within a pharmaceutical or technology organization Demonstrated expertise enabling technology for drug discovery research capabilities such as high throughput screening, high content imaging, in vitro assay technologies, compound inventory management, in vivo studies, digital pathology, PK/PD assessments, GLP tox studies, etc. Experience leading the implementation of scientific software platforms, Electronic Lab Notebook (ELN), and 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). 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 Strong analytical/critical-thinking and decision-making abilities Ability to work effectively in a fast-paced, dynamic environment Experience in establishing business partnerships and IS governance practices involving senior business collaborators Professional Certifications SAFe Agilist, Certified Agile Leader or similar (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.

Let s do this. Let s change the world. In this vital roleThe ideal candidate will have a proven track record of leadership and mentoring in technology-driven environment, with a strong focus within the Salesfore.com product lineup. The candidate should be a self-starter and have a strong passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with cross-functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have strong business analysis skills and technical background in end-to-end software development lifecycle. Proficiency in managing complex integration projects and ensuring compliance with privacy standards is essential. Roles & Responsibilities: Collaborate with business collaborators on end-to-end Commercial Marketing operations business process and translate business requirements into clear, actionable technical requirements for development teams Define and communicate the product feature vision, including both technical / architectural features and enablement, and end-user features, ensuring alignment with business objectives across multiple solution collaborator groups Collaborate with cross domain & cross functional collaborators, including Commercial Marketing owners to design, implement, and manage features Create strategic roadmap for Commercial Marketing applications to ensure that the applications continue to align with business process requirements Work with Product Owners, Service Owners and developers/testers to ensure that delivery matches commitments, acting as a partner concern point and facilitating communication when service commitments are not met Leverage cutting-edge AI/ML and cloud technologies to address Commercial Marketing needs and shape the vision for the Commercial Marketing software ecosystem. Oversee the software development lifecycle using Scaled Agile Framework (SAFe) Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Collaborate with geographically dispersed teams, including those in the US and other international locations. 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 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 8 - 10 years of experience in Business, Engineering, IT or related field OR Bachelor s degree with 10 - 14 years of experience in Business, Engineering, IT or related field OR Diploma with 14 - 18 years of experience in Business, Engineering, IT or related field Experience in implementation and management of integrated Salesforce.com platforms through the SDLC Experience in business requirement gathering and converting the requirements into a technical solution Has experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Demonstrated experience in managing technology initiatives and teams with a track record of successful innovation. Familiarity with security requirements and standard methodologies for data at rest and in transit Success in mentoring and developing strong product analysts, business analysts, and developers Exceptional collaboration, communication and interpersonal skills to effectively manage collaborator relationships and build new partnerships. Preferred Qualifications: Health Cloud and Lifesciences Cloud hands on experience Working knowledge of integrations and tools such as Mulesoft Extensive experience in the software development lifecycle Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytic/critical-thinking and decision-making abilities Established business partnerships and IS governance practices involving senior business collaborators Broad working knowledge of key IS domains and layers Professional Certifications: Salesforce Marketing Cloud Consultant (preferred) Scaled Agile Framework (SAFe) for Teams (preferred) Salesforce.com Administrator (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. Excellent analytical and troubleshooting skills Strong verbal and written communication 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.

Let s do this. Let s change the world. In this vital role you will responsible for leading and charting the course for the Research Data & Analytics (RDNA) team that builds and transforms data and analytics capabilities for Amgen s drug discovery research organization. This individual will be responsible for developing and leading a highly talented team that is built for delivering high-end and innovative technologies. As a scientific data domain expert, this role will collaborate with cross-functional teams to identify strategies for implementation and adoption of Amgen Research Foundational Data Systems. The ideal candidate will have a strong background in biopharma scientific domains as well as informatics solution delivery with a proven track record of leadership in technology-driven environments that facilitate data-driven 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 and Managers, coupled with leadership and transformation 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 strategic initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Lead and handle diverse teams within a matrixed organization. Collaborate with geographically dispersed teams, including those in the US, EU, and other international locations. Provide technology delivery leadership and domain expertise for RDNA product teams and capabilities. Partner with Research and Technology leaders to create technology delivery strategy and prioritized agenda for RDNA. Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities. Provide leadership for the creation of functional analytics dashboards and fit-for-purposes applications for quantitative research, scientific analysis and business intelligence (via Spotfire, Tableau, Dash, Posit, Streamlit, RShiny, etc.). Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations. Follow global standards and practices. Foster a culture of collaboration, innovation, and continuous improvement. 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 Amgen Technology team in India, ensuring global ways of working are embedded in the local organization. Understand the decision-making process, workflows, and business and information needs of business partners and collaborators. Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as a partner concern point and 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. Facilitate standard methodology sharing, ensuring ongoing alignment with the Technology & Digital strategy. Oversee operating budgets and product team budgets, ensuring regular review of actuals and latest estimates, managing according to agreed governance. Ensure alignment of Technology service plans across organization. Provide education to new partners with regards to Data and Analytics service offerings. Remain accountable for ensuring overall organizational compliance to quality/compliance requirements such as GXP and Privacy. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 8 to 10 years of Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Bachelor s degree and 10 to 14 years of Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Diploma and 14 to 18 years of Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field Familiarity with data analytics and scientific computing platforms such as Databricks, Dash, Streamlit, RShiny, Spotfire, Tableau and related programming languages like SQL, python, R Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data Demonstrated experience building strong teams with consistent practices in a matrix organization In-depth knowledge of Agile processes and principles for coordinated solutions and teams via SAFe Preferred Qualifications: Familiarity with advanced analytics, AI/ML and scientific computing infrastructure, such as High-Performance Compute (HPC) environments and clusters (e.g., SLURM, Kubernetes) 6+ years of experience in implementing and supporting biopharma scientific research data analytics. Experience in a leadership role within a pharmaceutical or technology organization Demonstrated expertise in a scientific domain area and related technology needs Understanding of scientific data strategy, data governance, data infrastructure Experience with cloud (e.g. AWS) and on-premise compute infrastructure Strong analytical/critical-thinking and decision-making abilities Ability to work effectively in a fast-paced, dynamic environment Experience in establishing business partnerships and IS governance practices involving senior business collaborators. Professional Certifications SAFe Agilist, Certified Agile Leader or similar (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.

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 techniques and procedures. In this position you will monitor activities through internal review and risk assessments of GxP systems per Amgen s policies and procedures. 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. As Senior Manager Quality Assurance in the IT Quality organization, you re in a leadership position with responsibilities to supervise and mentor staff. Each staff member will participate/support different phases of the Information Systems Lifecycle. As a leader you will focus your efforts on the following workflows in a GxP environment: Focus Areas Computer System Validation (CSV) with a strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards. Strong understanding of periodic reviews and audit trail assessments for computer system validations, ensuring compliance, system integrity, and risk identification. Manages supplier relationships for software applications, including vendor selection and qualification, contract management, and ensuring timely and quality software delivery. Oversees the Quality Management System (QMS) for computerized systems, ensuring compliance, documentation, and continuous process improvement. Responsibilities Strong project management skills with experience supervising quality professionals working with cross functional and global stakeholders across multiple time zones. Develop, Mentor, and oversee staff and day-to-day GxP activities. Assess and guide the team in performing Periodic Review of Systems and Audit Trail Reviews. Manage change controls, validation and review and approval of validation deliverables per procedure (e.g. Validation Plan, Test Strategy, Validation Summary Report, etc.). Supplier Management activities for Computerized Systems and other validation disciplines/processes (e.g. Equipment, Analytical, etc.) Support, review and approval of failure investigations & CAPA as a Quality Contact pertaining to Computer Systems. Business Owner activities for systems owned by Quality Assurance (e.g. SAP QM, Veeva, Kneat). Participation and support of regulatory inspections as needed. Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise , Documentation Management Systems. The following are some examples of tasks for the position Strong understanding of Risks Assessment and how to apply risk-based decision making to all processes related to IT systems. Determine and establish requirements for system/equipment or processes. Act as a reviewer and approver for SOPs, validation deliverables and /or QMS related records (Deviation/CAPA). Review and Approve System Life Cycle Documents (i.e. Validation deliverables). Apply analytical skills to evaluate and interpret complex situations/problems using multiple sources of information. Leverages qualitative insights and quantitative research, analyzes trending data, and utilizes forecasting models and advanced analytical tools to drive continuous improvement in IT quality and performance. Anticipates and prevents potential problems. Independently develop solutions that are thorough, practical and consistent with functional objectives. Provides management review updates on quality metrics, analyzing data and recommending improvements to enhance quality standards. Bring topics and critical decisions to management s attention and initiate and enforce necessary improvements and corrections to established systems and processes compliance. Basic Qualification Master s degree with a minimum of 10 years experience in Software and Systems Quality assurance (Experience of minimum 5 years in leading teams in this area of expertise and foster an environment of strong collaboration) OR Bachelor s degree with a minimum of 14 years experience in Software and Systems Quality assurance (Experience of minimum 5 years in leading teams in this area of expertise and foster an environment of strong collaboration). Strong understanding and ability to apply GxP requirements in Information systems. Possesses a strong understanding of industry standards and business principles. Contributes to work group/team by ensuring quality of tasks/ services provided by self and others. Candidate may need to work hours outside the standard workday or work in different time zones to support business needs. Preferred skills Demonstrated experience (3-5 years) training others in activities outline above. Establish/Improve and actively participate in training curriculum and delivery of this material. What we expect from you We are all different, yet we all use our unique contributions to serve patients. 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.

The Senior Manager - Technology, will lead and coordinate cross-functional technology teams with a focus on Omics and Multi-Omics product development to enable target and biomarker discovery. This role combines strategic leadership, product ownership, and operational oversight, with a strong emphasis on global collaboration. This hands-on leader is primarily responsible for maximizing the value delivered by the team by ensuring that the team backlog is aligned with end-user and stakeholders needs across R&D. This role involves close collaboration with Architecture and Engineering leads supporting product teams along with scientific community representative stakeholders across R&D to define and prioritize features and provide a roadmap for feature development. The ideal candidate has strong experience in product management, specifically related to products that deliver Omics data technologies that enable scientists to perform high throughput analytics to elucidate disease biology, mechanism of action and pathway analysis. The role requires exceptional communication skills, and a deep understanding of Agile methodologies. Roles & Responsibilities: Manage and mentor junior technology staff across product teams, fostering a culture of innovation, accountability, continuous improvement and a sense of belonging. Collaborate and align with global product owners to ensure product teams are committed and focused on delivering on SAFe PI objectives for the business Define and communicate the product feature vision, including both technical / architectural features and enablement, and end-user features, ensuring alignment with business objectives across multiple solution stakeholder groups Create, prioritize, and maintain the feature backlog, ensuring that it reflects the needs of the business and stakeholders Collaborate with stakeholders to gather and document product requirements, user stories, and acceptance criteria Work closely with the business teams, Scrum Master and development team to plan and execute sprints, ensuring that the highest priority features are delivered Identify opportunities to improve the product / platform / system and development process, and make data-driven decisions to enhance the product / platform Oversee the day-to-day management of technology platforms, ensuring that they meet performance, security, and availability requirements Manage relationships with product / platform /system vendors, ensuring that service levels are met and that the organization derives the best value from its investments Ensure that platforms comply with security standards, regulatory requirements, and organizational policies Oversee the management and operation of specific IT systems, ensuring that they meet performance, security, and availability requirements Manage product team Architects, Analysts and Validation Engineers and provide role-based standards and career mentorship for these roles Assure that the team is successfully creating robust written materials, including product documentation, product backlog and user stories, and creating other need artifacts to assure efficient and effective coordination across time zones. Analyze product performance data, customer behavior, and market trends to inform product decisions Create and maintain reports and dashboards that provide insights into product performance, user engagement, and other key metrics Conduct market research and competitive analysis to identify opportunities and inform product strategy Analyze customer feedback and support data to identify pain points and opportunities for product improvement What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications and Experience: Doctorate degree / Masters degree / Bachelors degree and 12 to 17 years of experience in Life Sciences, Computer Science, IT, Computational Biology/Bioinformatics or related field. Must-Have Skills: Strong knowledge of Agile methodologies (SAFe) and product management principles, and backlog and feature management tools including Jira and Confluence Strong knowledge of IT service management (ITSM) principles and methodologies Extensive experience in leading teams, mentoring junior professionals, and cultivating the next generation of talent Strong communication and organizational abilities with a proven capacity to manage multiple priorities effectively. Proven record of implementing technology solutions in a large organization Good-to-Have Skills: Good Knowledge of the Global Pharmaceutical Industry Understanding of GxP process Strong solution design and problem-solving skills Strong understanding of technology, function, or platform Experience in developing differentiated and deliverable solutions Ability to analyze client requirements and translate them into solutions Working late hours Professional Certifications: Experience with current cloud technologies (AWS, Azure etc.), use of AI and large language models (LLMs), programming languages (Python, R) Experience working in biopharma R&D with emphasis on implementing research technologies Knowledge of GxP system validation processes Soft Skills: Excellent analytical and troubleshooting skills Highest degree of initiative and self-motivation Strong verbal and written communication skills, including presentation of varied audiences through complex technical/business topics Confidence in leading teams through prioritization and sequencing discussions, including managing stakeholder expectations Ability to work effectively with global, virtual teams, leveraging tools and artifacts available to assure clear and efficient collaboration across time zones Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong problem solving, analytical skills Ability to learn quickly and retain and synthesize complex information from diverse sources 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. Equal opportunity statement

As a Sr. Digital Product Manager within Enterprise Data Strategy and Engineering (EDSE), youll play a key role in unlocking the power of data and intelligence to enable Amgen s mission of accelerating breakthrough therapies. You will help shape and deliver Data and AI products and capabilities that support Amgen s strategic goals. Working closely with capability leads, business key collaborators, and engineering teams, you ll define solution roadmaps and set go-to-market strategies that drive adoption and measurable outcomes. This role is ideal for someone who enjoys shaping product direction, scoping new opportunities and delivering measurable outcomes. Youll contribute to the broader data strategy by ensuring that products and capabilities are positioned effectively and adopted meaningfully. Lead product discovery with internal customers to surface problems worth solving and define valuable, feasible solutions Shape product strategy and roadmap aligned to enterprise priorities and capability vision Own go-to-market strategy, driving adoption and engagement across the business Use AI tools and rapid iteration methods to prototype, validate, and define product requirements Translate insights into clear, actionable specs that engineering teams can complete Measure and track product outcomes, not just output, to ensure continuous value delivery Partner with business and technical leaders to position internal capabilities effectively Mentor Product Analysts and help build strong internal product practice as the team grows Define product and capability roadmaps aligned to business needs and enterprise data strategy Work with delivery teams to ensure timely execution and solution alignment As the function scales, you ll also play a key role in building and leading a team of Product Analysts, contributing to a growing internal product management practice What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree / Masters degree / Bachelors degree and 12 to 17 years of experience in Information/Tech Systems Proven ability to lead product lifecycle end-to-end, from strategy through execution Demonstrated ability to innovate by leveraging AI tools to enhance product impact and accelerate outcomes Strong experience crafting and implementing go-to-market strategies Excellent communication skills and ability to work across business and technology functions Familiarity with data, analytics, and AI platforms or related technologies Agile delivery experience in a matrixed environment Excellent project management skills with a record of building strong partnerships across multi-functional teams and managing diverse workloads to meet deadlines. Ability to work autonomously with minimal guidance and know when to seek input, combined with a collaborative approach to align with and support project goals Preferred Qualifications: Relevant experience, with overall experience in above mentioned range, in a product management role preferably in Data, AI and related platforms. Experience in leading products, defining roadmap and tracking the success of the product. Develop and align product strategy to the organizational strategy. Experience with Agile methodologies (Scrum/SAFe). Excellent critical thinking, problem solving, and communication skills Preferred Qualifications: Familiarity with cloud technologies, data platforms, and business intelligence (BI) tools and solutions Ability to work and lead effectively across matrixed organizations and collaborate between data and AI teams. Passion for technology and product success, particularly in driving innovative AI and data solutions. Experience in technology products related to data and AI products is a plus, and familiarity with biotech/pharma is beneficial. Soft Skills: Strong presentation and public speaking skills with experience communicating to Sr. leaders Excellent analytical and solving skills. Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to handle multiple priorities successfully. Team-oriented, with a focus on achieving team goals 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.

The Global Submission and Information Management (GSIM) team brings strategic technical expertise to drive operational excellence, innovation, and technical compliance for Amgens global regulatory submission and information management. Ensures smooth, compliant data flows among functional areas, external partners, and regulatory authorities while designing and implementing process improvements, digital technologies, data standards, and organizational change management to achieve business results. The Senior Manager of Regulatory Data Management will help shape and implement the system based framework for regulatory data management at Amgen. The role involves leading the Data Management team in AIN, engaging with GSIM leadership and cross-functional partners who use the company Regulatory Information Management system. This role is pivotal in building and leading an impactful team from the ground up, ensuring the delivery of key operational metrics and maintaining compliance. Build and lead an impactful team, focused on delivering global regulatory data management services within the regulatory information management system. Develop a collaborative and inclusive team culture that promotes innovation and continuous improvement. Ensure the team meets key operational metrics and compliance standards, maintaining high levels of accuracy and efficiency. Drive continuous improvement initiatives to enhance service delivery and operational processes. Minimize potential errors by establishing policies & processes for data usage. Supervise the provision of high-quality data processing, system utilisation and data management services to global clients. Develop and implement comprehensive training programs to ensure team members are skilled and knowledgeable in regulatory data management practices. Stay abreast of regulatory developments and ensure the team is follows all relevant regulations and standards. What we expect of you Basic Qualifications: Doctorate degree and 2 years of regulatory systems experience OR Master s degree and 8 to 10 years of regulatory systems experience OR Bachelor s degree and 10 to 14 years of regulatory systems experience OR Diploma and 14 to 18 years of regulatory systems experience OR Advanced knowledge of Veeva Vault RIM Proven leadership in regulatory data management Hands-on ability to work on data-centric processes and systems. Strong Knowledge of handling structured and unstructured data Demonstrated excellence in change management and key customer engagement. Preferred Qualifications: Experience with delivering compliance assurance within a large company Experience with large-scale enterprise systems in the Biotech/Pharmaceutical industry. 5 years of proven experience in regulatory operations, submission management. Excellent understanding of Regulatory Affairs business complexity and process interdependencies Experience with regulatory data in Regulatory Affairs, Research, Development, Quality Management, or related area. Demonstrated experience in building and leading successful teams. Sharp learning agility and analytical thinking Proven and advanced interaction with global key customers 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.

Let s do this. Let s change the world. In this vital role you will lead an Agile product squad and responsible for defining the vision & strategy and implementation for a range of Clinical Data products supporting Amgen Clinical Trial Design & Analytics. You will collaborate closely with statisticians, data scientists, data engineers, and AI/ ML engineers teams to understand business needs, identify system enhancements, and drive system implementation projects. Your extensive experience in business analysis, system design, and project management will enable you to deliver innovative and effective technology products. Roles & Responsibilities: Define and communicate the product feature vision, including both technical / architectural features and enablement, and end-user features, ensuring alignment with business objectives across multiple solution collaborator groups Create, prioritize, and maintain the feature backlog, ensuring that it reflects the needs of the business and collaborators Collaborate with collaborators to gather and document product requirements, user stories, and acceptance criteria Work closely with the business teams, Scrum Master and development team to plan and implement sprints, ensuring that the highest priority features are delivered Oversee the day-to-day management of technology platforms, ensuring that they meet performance, security, and availability requirements Ensure that platforms comply with security standards, regulatory requirements, and organizational policies Assure that AIN team is successfully creating robust written materials, including product documentation, product backlog and user stories, and creating other need artifacts to assure efficient and effective coordination across time zones. Oversee the resolution of service-related incidents and problems, ensuring minimal impact on business operations Maintains in-depth knowledge of clinical development business domains with an emphasis in data assets and data pipelines, as well as an understanding of the multi-functional dependencies. Analyze customer feedback and support data to identify pain points and opportunities for product 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 and 8 to 10 years of Information Systems experience OR Bachelor s degree and 10 to 14 years of Information Systems experience OR Diploma and 14 to 18 years of Information Systems experience A solid foundation in modern software design and engineering practices and business analysis. Proven experience in undemanding and gather business requirements and delivered insight, and achieved concrete business outcome. Technical Proficiency: Good understanding of the following technologies: Python, R, AI/ML frameworks, relational databases/data modeling, AWS services ( EC2, S3, Lambda, ECS, IAM), Docker and CI/CD/Gitlab, Apache/Databricks, Expert understanding and experience of clinical development process within Life Sciences (global clinical trial data sources, SDTM & AdaM, end-to-end clinical data design and analysis pipeline, clinical data security and governance) Experience in Agile product development as a participating member of a scrum team and related ceremonies and processes Ability to collaborate with data scientists and data engineers to deliver functional business requirements as well defining product roadmap. High learning agility, demonstrated ability of quickly grasp ever changing technology and clinical development domain knowledge and applied to the project work. Strong communications skills in writing, speaking, presenting and time management skills. Preferred Qualifications: Training or education degree in Computer Science, Biology, or Chemistry. Experience with Clinical Data and CDISC (SDTM and ADaM) standard Soft Skills: Excellent analytical and troubleshooting skills Deep intellectual curiosity, particularly about data patterns, and learning about business processes and life of the user Highest degree of initiative and self-motivation Strong verbal and written communication skills, including presentation of varied audiences through complex technical/business topics Confidence in leading teams through prioritization and sequencing discussions, including managing collaborator expectations Ability to work effectively with global, virtual teams, specifically including leveraging of tools and artifacts to assure clear and efficient collaboration across time zones Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong problem solving, analytical skills; Ability to learn quickly and retain and synthesize complex information from diverse sources 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.

Let s do this. Let s change the world. n this vital role you will develop an insight driven sensing capability with a focus on revolutionizing decision making. In this role you will lead the technical delivery for this capability as part of a team data engineers and software engineers. The team will rely on your leadership to own and refine the vision, feature prioritization, partner alignment, and experience leading solution delivery while building this ground-breaking new capability for Amgen. You will drive the software engineering side of the product release and will deliver for the outcomes. Roles & Responsibilities: Lead delivery of overall product and product features from concept to end of life management of the product team comprising of technical engineers, product owners and data scientists to ensure that business, quality, and functional goals are met with each product release Drives excellence and quality for the respective product releases, collaborating with Partner teams. Impacts quality, efficiency and effectiveness of own team. Has significant input into priorities. Incorporate and prioritize feature requests into product roadmap; Able to translate roadmap into execution Design and implement usability, quality, and delivery of a product or feature Plan releases and upgrades with no impacts to business Hands on expertise in driving quality and best in class Agile engineering practices Encourage and motivate the product team to deliver innovative and exciting solutions with an appropriate sense of urgency Manages progress of work and addresses production issues during sprints Communication with partners to make sure goals are clear and the vision is aligned with business objectives Direct management and staff development of team members What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 8 to 10 years of Information Systems experience OR Bachelor s degree and 10 to 14 years ofInformation Systems experience OR Diploma and 14 to 18 years of Information Systems experience Thorough understanding of modern web application development and delivery, Gen AI applications development, Data integration and enterprise data fabric concepts, methodologies, and technologies e.g. AWS technologies, Databricks Demonstrated experience in building strong teams with consistent practices. Demonstrated experience in navigating matrix organization and leading change. Prior experience writing business case documents and securing funding for product team delivery; Financial/Spend management for small to medium product teams is a plus. In-depth knowledge of Agile process and principles. Define success metrics for developer productivity metrics; on a monthly/quarterly basis analyze how the product team is performing against established KPI s. Functional Skills: Leadership: Influences through Collaboration : Builds direct and behind-the-scenes support for ideas by working collaboratively with others. Strategic Thinking : Anticipates downstream consequences and tailors influencing strategies to achieve positive outcomes. Transparent Decision-Making : Clearly articulates the rationale behind decisions and their potential implications, continuously reflecting on successes and failures to enhance performance and decision-making. Adaptive Leadership : Recognizes the need for change and actively participates in technical strategy planning. Preferred Qualifications: Strong influencing skills, influence stakeholders and be able to balance priorities. Prior experience in vendor management. Prior hands-on experience leading full stack development using infrastructure cloud services (AWS preferred) and cloud-native tools and design patterns (Containers, Serverless, Docker, etc.) Experience with developing solutions on AWS technologies such as S3, EMR, Spark, Athena, Redshift and others Familiarity with cloud security (AWS /Azure/ GCP) Conceptual understanding of DevOps tools (Ansible/ Chef / Puppet / Docker /Jenkins) Professional Certifications AWS Certified Solutions Architect (preferred) Certified DevOps Engineer (preferred) Certified Agile Leader or similar (preferred) Soft Skills: Strong desire for continuous learning to pick new tools/technologies. High attention to detail is essential with critical thinking ability. Should be an active contributor on technological communities/forums Proactively engages with cross-functional teams to resolve issues and design solutions using critical thinking and analysis skills and best practices. Influences and energizes others toward the common vision and goal. Maintains excitement for a process and drives to new directions of meeting the goal even when odds and setbacks render one path impassable Established habit of proactive thinking and behavior and the desire and ability to self-start/learn and apply new technologies Excellent organizational and time-management 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. 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.

Let s do this. Let s change the world. In this vital role you will own and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. The Senior Associate conducts low to medium complexity complaint investigations and determines if complaint investigations require issue for further investigation. Evaluates and ensures triaged product complaint records align with applicable procedures Evaluates and owns complaint records with basic investigations Ensures quality of complaint records Completes assigned assessments per applicable procedures Applies analytical skills to evaluate sophisticated situations using multiple sources of information Implements the complaint process per SOP requirements Owns or manages the review/approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guide Supports management of assigned projects or project tasks to achieve agreed results within time and with encouraged quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of Quality experience OR Bachelor s degree and 3 to 5 years of Quality experience OR Diploma and 7 to 9 years of Quality experience Preferred Qualifications: Quality and/or manufacturing experience in biotech, medical device or pharmaceutical industry Bachelor s Degree in a Science Field Ability to successfully manage workload to timelines Familiarity with basic project management tools Ability to operate in a matrixed or team environment with site, functional, and senior management leadership Experience in driving decision making by using the DAI principles Understanding of quality and industry requirements/expectations of a QMS Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Ability to negotiate a position after taking feedback from multiple sources Demonstrated ability to lead functional teams, consistently deliver timely, and high-quality results Ability to translate business and key collaborator feedback and requirements into accurate and efficient processes using clear language and format 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.