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Job Description
 

Principal Scientist in Biologics Analytical Development (Pivotal and Commercial). Foster City, CA

United States - California – Oceanside, CA or Foster City, CA

Job Description:

We are seeking a highly motivated and experienced Principal Scientist to join the Biologics Structural Characterization team within Pivotal and Commercial Analytical Development. This role will provide scientific and people leadership for mass spectrometry–based characterization with a primary focus on critical post‑translational modifications (PTMs), intact and subunit mass analysis across a range of late‑stage biologics programs, to support product understanding, control strategy, and regulatory filings from late development through commercialization.

The successful candidate will serve as a technical expert in MS‑based structural characterization, act as a mentor to junior scientists, and bring demonstrated experience in managing and developing MS teams within a regulated CMC environment.

This role is designed to bridge deep MS technical expertise with people leadership, enabling robust PTM, intact and subunit mass characterization in support of late‑stage biologics development and commercialization.

 The position will be on-site at Oceanside, CA with a future transfer to Foster City, CA.

Key Responsibilities

• Provide scientific and people leadership to a team of scientists focused on extended characterization analysis, for example, PTM characterization, intact and subunit mass analysis for biologics.

• Mentor, coach, and develop junior scientists; set clear expectations, performance goals, and scientific standards.

• Lead and oversee MS‑based structural characterization strategies, including intact mass, subunit analysis, peptide mapping, and PTM profiling (e.g., oxidation, deamidation, clipping, disulfide integrity, glycation, terminal variants, etc.).

• Define and drive late‑stage characterization and control strategies in alignment with CQAs and product quality targets.

• Serve as an analytical project lead (ASTL) or senior analytical representative for late‑phase programs, ensuring timely delivery of high‑quality characterization data.

• Author and review CMC sections for IND, BLA, and post‑approval submissions, and support interactions with global health authorities.

• Partner cross‑functionally with Process Development, Quality, Manufacturing, CMC Regulatory Affairs, Technical Development, and Supply Chain to support commercialization and lifecycle management.

• Drive adoption of state‑of‑the‑art MS technologies and workflows, including high‑resolution MS, native MS, multi‑attribute methods (MAM), and data‑driven characterization approaches.

• Ensure compliance with GMP, data integrity, and CMC regulatory expectations.

• Contribute as a member of the extended Analytical Development leadership team, influencing strategy, resourcing, and capability building.

Qualifications

• Ph.D. with 8+ years or M.S. with 10+ years of industry experience in Analytical Chemistry, Biochemistry, or related fields, with significant experience in biologics structural characterization.

• Deep expertise in mass spectrometry, particularly intact mass analysis, peptide mapping, and PTM characterization for biologics.

• At least three years of experience leading and managing MS teams, including mentoring, hiring, and performance development.

• Strong understanding of CMC, CQAs, comparability, spec