Gilead Sciences · 1 day ago
Principal Scientist, External Quality Testing
San Francisco Bay Area
Full-time
Onsite
Senior Level, Lead/Staff
$196K/yr - $253K/yr
5+ years expGilead Sciences is dedicated to creating a healthier world for all people by tackling major diseases and developing life-changing therapies. As a Principal Scientist, you will provide strategic leadership for External QC operations, ensuring compliance and excellence in quality control for commercial biologics.
BiotechnologyHealthcarePharmaceuticalManufacturingBiopharmaHealth Care
Responsibilities
Provide strategic leadership and oversight for External QC operations supporting Gilead’s commercial biologics portfolio, setting long‑term direction for QC excellence
Lead the strategy and execution of release testing for commercial biologics drug substances and drug products, ensuring delivery of compliant, reliable analytical data
Develop and drive commercial specification strategies and oversee the life‑cycle management of reference standards and critical reagent programs
Lead analytical method validation and transfer strategies, ensuring methods remain robust, current, and aligned with global regulatory expectations
Direct the compendial review program, assessing emerging pharmacopeial changes and defining strategic responses to maintain compliance
Guide the monitoring of QC test method execution across the biologics network and drive improvements to ensure consistency, harmonization, and operational efficiency
Ensure all QC activities align with global cGMP and Gilead’s Quality Management System, while shaping the future state of QC capabilities and quality systems
Qualification
Required
Broad experience across QC sub‑functions with deep knowledge of current and emerging industry best practices and trends
In‑depth understanding and application of cGMP principles, standards, and global regulatory expectations
Demonstrated ability to develop and improve complex quality concepts, techniques, standards, and novel applications
Proven track record in solving complex problems using creativity, innovation, and strategic thinking
Ability to independently exercise judgment, make decisions without precedent, and set strategic direction in ambiguous situations
Experience partnering with senior leadership to develop and implement company‑wide, long‑term solutions
Demonstrated ability to define a vision for QC functions and shape organizational capabilities to fulfill that vision
Strong influencing and cross‑functional leadership skills with the ability to drive outcomes across multiple teams
Strong organizational planning, communication, and collaborative interpersonal skills
Critical and creative thinker able to work independently and identify appropriate resources to resolve challenges
10+ years' experience with a BS, OR
8+ years' experience with a MS OR
5+ years' experience with a PhD
Chemistry, Biochemistry or related field
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2026-02-06
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2026-02-06
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