Research Scientist - Product development

Overview

Research Scientist on Elanco’s Biopharma Technical Development (BTD) Analytical Development team, providing scientific leadership for analytical activities across biotechnology therapeutics programs.

What you'll do

• Oversee analytical method transfer activities to internal/external laboratories, CROs, and CDMOs.
• Provide technical oversight across the analytical method lifecycle (transfer, qualification, validation, troubleshooting, lifecycle support).
• Partner with sending and receiving site SMEs to prepare, execute, monitor, and close out analytical transfers.
• Manage external vendor/CRO/CDMO relationships and deliverables, escalating technical risks and issues.
• Evaluate analytical data, transfer outcomes, deviations, and method performance trends to identify risks and mitigation.
• Author/review technical documents and ensure compliance with GMP/GRP and applicable quality/regulatory requirements.
• Support analytical readiness for clinical trial supply, qualification/validation, registration, and commercial supply as applicable.

What you'll need

• Ph.D. in a related field (biology/analytical chemistry/biochemistry) with at least 2 years of pharmaceutical industry experience, or M.S. with 4 years, or B.S. with 8 years.
• Experience supporting the analytical method lifecycle for biologics in a regulated environment.
• Experience working with external vendors, CROs, and/or CDMOs.
• Strong understanding of analytical methods for biologics and ability to build knowledge of product/process attributes for transfer success.
• Experience with biologics analytical methods such as HPLC, CE, and ELISA.
• Strong technical writing and document review skills.
• Risk assessment, problem-solving, and communication skills.

Details

• Location: Bangalore, India.
• Travel to sending and/or receiving sites as needed.