Research Scientist - Product development

About the role

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

What you'll do

• Oversee all aspects of analytical method transfer activities for biopharmaceutical products to internal and/or external laboratories, CROs, and CDMOs
• Evaluate analytical data, transfer outcomes, deviations, and method performance trends to identify technical risks and drive appropriate mitigation strategies
• Collaborate with QA and Regulatory partners to ensure analytical activities and documentation meet internal expectations and global quality standards

What you need

• 8–14 yrs of experience
• Research
• HPLC
• Technical writing
• Risk management
• GMP
• Biology
• PhD

Good to have

• Chemistry