Head of Analytical Development

Head of Analytical Development

Location: On-site near Union City, CA

Industry: Biopharmaceuticals / Biologics

A pioneering biopharmaceutical innovator in the Bay Area is expanding its R&D leadership and seeking a Head of Analytical Development. This role is vital to advancing the company’s innovative therapies pipeline, particularly within biologics, through scientific excellence, method innovation, and regulatory strategy. The company is preparing for pivotal product milestones and regulatory interactions, offering a high‑impact role for a scientific leader ready to shape analytical development strategy and lead a cross‑functional team.

• Provide strategic, scientific, and operational leadership across the analytical development function supporting biologics programs from early phase through commercialization.
• Lead development, optimization, validation, and transfer of analytical methods for drug substances, drug products, and non‑compendial raw materials.
• Design and direct complex extended characterization studies to support regulatory filings and technical documentation.
• Collaborate cross‑functionally with internal teams (Process Development, MSAT, Quality, Regulatory) and external partners (CROs, CDMOs, CTLs) to ensure analytical alignment across development stages.
• Guide laboratory operations and provide scientific mentorship to a team of scientists and technical leaders.
• Oversee stability studies of critical reagents and engineering/non‑GMP batches to support formulation and manufacturing decisions.
• Act as the analytical SME in cross‑functional teams and represent analytical function in CMC development and regulatory discussions.

• B.S. in biological sciences or related discipline with 8+ years (or M.S. with 6+ years) of progressive analytical development experience in the biotech or pharmaceutical industry.
• Proven experience leading scientific teams and mentoring scientists in an analytical development setting.
• Expertise in a broad range of analytical techniques such as SDS‑PAGE, chromatography (HPLC/UPLC), CE‑SDS, icIEF, ELISA, western blotting, and cell‑based potency assays.
• Hands‑on experience with advanced characterization techniques such as AUC, LC/MS, DLS, NMR, and circular dichroism.
• Demonstrated success in method development, validation, tech transfer, and authoring CMC documentation for regulatory submissions.
• Familiarity with DoE approaches and statistical tools like JMP, R, or Python.
• GxP experience and strong understanding of quality and regulatory standards.

• Ph.D. in chemistry, biochemistry, pharmaceutical sciences, or related discipline.
• Experience in extended characterization (e.g., SEC‑MALS, peptide mapping, disulfide mapping, PTM analysis).
• Background in neurotoxin or biologics development is a strong plus.
• Experience overseeing CRO/CDMO relationships and managing analytical‑related quality documentation such as deviations, change controls, and investigations.

• Be at the forefront of biologic drug development in a high‑growth company committed to improving patient outcomes.
• Influence CMC strategy and product development in a collaborative, science‑first environment.
• Join a mission‑driven culture that values innovation, scientific rigor, and operational excellence.
• Competitive compensation, bonus eligibility, comprehensive healthcare, flexible PTO, and professional development support.