Principal Scientist/Associate Director, Analytical Development

Responsibilities

• Support analytical method development, qualification, transfer, and lifecycle management for drug substance and drug product testing.
• Contribute to specifications and control strategies across various development stages.
• Lead and coordinate QC activities to support cGMP compliance and project objectives.
• Oversee external testing for release, characterization, comparability, and stability studies.
• Serve as the technical liaison for CDMOs, CROs, and contract testing laboratories.
• Review, interpret, and trend analytical data from release and stability studies.
• Author, review, and approve technical and GMP documents, including CMC sections for INDs.
• Promote alignment of analytical strategies and quality expectations across internal and external teams.

Requirements

• Degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related discipline.
• PhD with 8+ years of relevant industry experience, MS with 12+ years, or BS with 14+ years.
• Expertise in analytical development for biologics and mAbs (chromatographic, electrophoretic, immunological, and potency-based methods).
• Proven experience providing technical oversight of external CRO/CDMO analytical operations.
• Strong working knowledge of CMC regulatory expectations for global submissions.
• Demonstrated success in developing and implementing novel analytical methods.

Preferred Qualifications

• Experience with other modalities such as peptides and nucleic acids.
• Experience developing, qualifying, and troubleshooting cell-based potency assays.
• Familiarity with statistical and data analysis tools like JMP and Excel.

About the Company

Pioneering Medicines is Flagship Pioneering’s in-house drug development unit. We are dedicated to conceiving and developing a broad portfolio of life-changing treatments built from Flagship’s innovative scientific platforms. We work at the intersection of life science innovation and drug development to accelerate therapeutic breakthroughs for patients worldwide.