Research Scientist - Product development

About this role

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Skills you'll use

What you'll do

• Oversee all aspects of analytical method transfer activities for biopharmaceutical products to internal and/or external laboratories, CROs, and CDMOs.
• Serve as an embedded analytical representative within project teams, working closely with AD and PD SMEs to develop a deep technical understanding of the process, product, and analytical methods before and during transfer activities.
• Provide technical oversight across the analytical method lifecycle, including method transfer, qualification, validation, troubleshooting, and ongoing lifecycle support for biologics programs.
• Partner with sending and receiving site SMEs to prepare, execute, monitor, and close out analytical transfers, ensuring alignment on scope, readiness, acceptance criteria, and technical expectations.
• Manage technical relationships and project deliverables with external vendors, CROs, and CDMOs, ensuring timely execution of agreed activities and rapid escalation of technical risks, gaps, and issues.
• Evaluate analytical data, transfer outcomes, deviations, and method performance trends to identify technical risks and drive appropriate mitigation strategies.
• Author, review, and edit technical documents, protocols, reports, method transfer packages, and supporting regulatory or quality documentation, ensuring compliance with Good Manufacturing Practice (GMP), Good Research Practice (GRP), and other applicable quality and regulatory requirements.
• Communicate regularly with technical teams, project leads, and senior leadership regarding project progress, key decisions, risks, dependencies, and mitigation plans.
• Collaborate with QA and Regulatory partners to ensure analytical activities and documentation meet internal expectations and global quality standards.
• Support analytical readiness for clinical trial supply, process performance qualification/validation activities, registration, and commercial supply as applicable to the program stage.

Who can apply

• · Education: Ph.D. in biology, analytical chemistry, biochemistry, or a related field with a minimum of 2 years of experience in the pharmaceutical industry; or M.S. in a related field with a minimum of 4 years of experience; or B.S. in a related field with a minimum of 8 years of experience.
• · Required Experience: Demonstrated experience supporting the analytical method lifecycle for biologics, including method transfer, qualification, validation, and technical troubleshooting in a regulated environment. Experience working with external vendors, CROs, and/or CDMOs is required.
• · Technical Know-How: Strong scientific understanding of analytical methods used to support biologic products and the ability to quickly build working knowledge of product and process attributes relevant to method performance and transfer success. Must be able to partner effectively with AD and PD SMEs to translate technical understanding into robust transfer strategy and execution.
• · Top Skills: Demonstrated experience with analytical methods for biologics (e.g., monoclonal antibodies, vaccines) using techniques such as HPLC, CE, and ELISA; strong technical writing and document review skills; ability to manage cross-functional and external technical relationships; strong risk assessment, problem-solving, and communication skills.

About Elanco

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