Principal Scientist, Analytical Ops

Principal Scientist in Biologics Analytical Development

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

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, specifications, and control strategies for late‑stage biologics. Proven track record of mass spectrometry expertise, including PTM and intact mass characterization, with demonstrated scientific impact through publications, internal innovations, or program support. Experience with relevant techniques may include (but is not limited to): high‑resolution LC‑MS, intact and subunit analysis, peptide mapping, MAM, SEC‑MS, IEX‑MS, RP‑LC, native MS, and complementary biophysical methods. Solid knowledge of FDA, EMA, and ICH guidelines related to biologics development and commercialization. Strong collaboration, communication, and stakeholder‑management skills in a cross‑functional environment. Strong business acumen, with ability to balance resource, budget, and program milestones.

Leadership Competencies

• Develop Talent: Actively mentor and grow scientific talent; provide timely feedback and career guidance.
• Build High‑Performing Teams: Foster accountability, inclusion, and collaboration.
• Strategic Mindset: Translate scientific insights into CMC and business impact.
• Executive Presence: Communicate complex technical concepts clearly to diverse audiences.

The salary range for this position is: $195,670.00 - $253,220.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.