Principal Scientist, Analytical Ops

Responsibilities

• Provide scientific and people leadership for a team of scientists focused on extended characterization analysis, including PTM profiling and intact/subunit mass analysis.
• Lead and oversee MS-based structural characterization strategies to support product understanding and control strategies.
• Mentor, coach, and develop junior scientists by setting clear performance goals and scientific standards.
• Serve as an analytical project lead (ASTL) for late-phase programs, ensuring the timely delivery of high-quality characterization data.
• Author and review CMC sections for IND, BLA, and post-approval regulatory submissions.
• Partner cross-functionally with Process Development, Quality, Manufacturing, and Regulatory Affairs to support commercialization.
• Drive the adoption of state-of-the-art MS technologies, such as high-resolution MS, native MS, and multi-attribute methods (MAM).
• Ensure strict compliance with GMP, data integrity, and CMC regulatory expectations.

Requirements

• Ph.D. with 8+ years of industry experience or M.S. with 10+ years in Analytical Chemistry, Biochemistry, or a related field.
• Deep expertise in mass spectrometry, specifically intact mass analysis, peptide mapping, and PTM characterization for biologics.
• At least 3 years of experience leading and managing MS teams, including hiring and performance development.
• Strong understanding of CMC, CQAs, comparability, and control strategies for late-stage biologics.
• Solid knowledge of FDA, EMA, and ICH guidelines related to biologics development and commercialization.
• Proven track record of scientific impact through program support or technical innovation.

Preferred Qualifications

• Experience with high-resolution LC-MS, MAM, SEC-MS, IEX-MS, and native MS.
• Strong business acumen with the ability to balance resources, budgets, and program milestones.
• Excellent stakeholder management and communication skills for presenting complex technical concepts to diverse audiences.

About the Company

Gilead Sciences is a research-based biopharmaceutical company that has tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer for more than 35 years. We work relentlessly to develop therapies that improve lives and ensure global access to life-changing scientific innovations.