Research Scientist - Product development

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Position Description:

·       As a Research Scientist on the Biopharma Technical Development (BTD) Analytical Development team, you are responsible for providing scientific and technical leadership for analytical activities across Elanco’s biotechnology therapeutics programs. This role has a particular focus on technical transfer activities and oversight of analytical method-related work at internal and external partners, including 3rd party CDMOs. The incumbent is expected to work as an integrated member of cross-functional project teams and partner closely with Analytical Development (AD) and Process Development (PD) subject matter experts to build a strong understanding of the product, process, control strategy, and analytical methods supporting the program.

·       The individual will apply this technical knowledge and experience to support successful analytical method transfer, qualification, validation, troubleshooting, and lifecycle management activities. This includes working extensively with sending site and receiving site SMEs to ensure on-time delivery, high-fidelity transfer execution, and effective resolution of technical issues and risks. The role will collaborate closely with biopharma CMC teams, technical project leads, quality, regulatory, and senior leadership to ensure clear, concise, and timely communication of project activities, milestones, gaps, and mitigation plans.

·       Overall, the Research Scientist will serve an essential function in bridging internal analytical development teams with both internal and external manufacturing partners, ensuring analytical readiness and successful support of clinical and commercial supply, registration activities, and broader program execution.

Functions, Duties, Tasks:

• 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.
• Travel to sending and/or receiving sites as needed to support successful analytical transfer execution, technical alignment, and timely issue resolution.

Minimum Qualification (education, experience and/or training, required certifications):

·       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.

Additional Preferences:

• Thorough understanding of GMP/GRP requirements and quality systems, with experience applying them from early-phase through late-phase development.
• Experience with statistical approaches to experimental design (DoE) and the ability to analyze, interpret, and document complex data.
• Demonstrated ability to lead and contribute to technical risk assessments or root cause investigations.

A collaborative mindset with experience fostering connections and sharing best practices across global teams and external partners.

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

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