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Confidential

Head of Analytical Development

Confidential, Union City, California, United States, 94587

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Head of Analytical Development About the Company

Promising biopharmaceutical company

Industry Biotechnology

Type Privately Held About the Role

The Company is in search of a Head of Analytical Development to play a pivotal role in advancing its innovative therapies pipeline, particularly within biologics. The successful candidate will be responsible for providing strategic, scientific, and operational leadership across the analytical development function, supporting biologics programs from early phase through commercialization. This includes leading the development, optimization, validation, and transfer of analytical methods, designing and directing complex extended characterization studies, and ensuring analytical alignment across development stages through cross-functional collaboration. The role also involves guiding laboratory operations, overseeing stability studies, and acting as the analytical subject matter expert in CMC development and regulatory discussions.

Applicants for the Head of Analytical Development position at the company should have a B.S. in biological sciences or a related discipline with at least 8 years of progressive analytical development experience in the biotech or pharmaceutical industry, or an M.S. with at least 6 years. A Ph.D. is preferred. The ideal candidate will have a proven track record in leading scientific teams, mentoring scientists, and expertise in a broad range of analytical techniques. Hands-on experience with advanced characterization techniques and a strong understanding of quality and regulatory standards are essential. Familiarity with DoE approaches, statistical tools, and GxP experience is also required. The role demands a scientific leader ready to shape analytical development strategy and lead a cross-functional team in a high-impact, mission-driven environment.

Travel Percent Less than 10%

Functions

Data Management/Analytics