Principal Scientist, Analytical Operations
Gilead Sciences
August 20, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
As a Principal Scientist, Analytical Operations, act as a Quality Control (QC) Lead responsible for strategic oversight and operational execution of cGMP analytical testing supporting small molecule clinical development programs.
Focus Areas
Quality Control Leadership & Strategy
- Define, implement, and continuously improve QC strategy aligned with CMC/quality objectives.
- Point of contact for QC activities: method validation/transfer, reference materials, specifications, cGMP release testing, stability strategy/testing, and supervision at external contract labs.
- Develop/maintain phase-appropriate QC strategies and processes for manufacturing and regulatory submissions.
- Manage/approve specifications; establish scientifically sound, phase-appropriate specs aligned with analytical capability and clinical/regulatory expectations.
- Represent QC on cross-functional product development teams.
- Drive improvement in QC testing, workflows, data management, and compliance.
- Identify/escalate QC risks and communicate to stakeholders.
Analytical Testing & Documentation
- Ensure compliant QC testing execution for raw materials, intermediates, drug substance, and drug product.
- Oversee timely QC documentation (test methods, protocols, reports, CoAs, quality records).
- Oversee contract labs to ensure on-time delivery and cGMP/data integrity compliance.
- Lead timely resolution of QC testing investigations (root cause, risk assessment, CAPAs).
Compliance & Regulatory Affairs
- Ensure QC compliance with cGMP, FDA, EMA, ICH, and applicable regulations.
- Drive data integrity, documentation, and traceability.
- Draft/review CMC sections and supporting documents; respond to RTQs.
Cross-Functional Collaboration
- Partner with Analytical Development, Manufacturing, QA, Regulatory, and Supply Chain.
- Support technology transfer and method implementation.
- Provide QC input for product development and submission documentation.
Requirements & Qualifications
- 10+ years (BS) OR 8+ years (MS) OR 5+ years (PhD/PharmD) in a related field.
- Hands-on leadership experience in small molecule analytical testing and QC.
- Experience with parenterals, medical device, and combination products.
- Experience establishing analytical specifications; authoring CMC sections.
- Deep understanding of regulatory and phase-appropriate clinical QC expectations.
- Experience managing testing at external labs.
- Strong scientific judgment, communication, cross-functional collaboration, influencing.
- Ability to organize/plan multiple tasks with shifting priorities; think critically/creatively and work independently.
People Leader Accountabilities
- Create Inclusion; Develop Talent; Empower Teams.
Compensation/Benefits (as stated)
- Salary range: $195,670.00–$253,220.00.
- May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits including company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.
Focus Areas
Quality Control Leadership & Strategy
- Define, implement, and continuously improve QC strategy aligned with CMC/quality objectives.
- Point of contact for QC activities: method validation/transfer, reference materials, specifications, cGMP release testing, stability strategy/testing, and supervision at external contract labs.
- Develop/maintain phase-appropriate QC strategies and processes for manufacturing and regulatory submissions.
- Manage/approve specifications; establish scientifically sound, phase-appropriate specs aligned with analytical capability and clinical/regulatory expectations.
- Represent QC on cross-functional product development teams.
- Drive improvement in QC testing, workflows, data management, and compliance.
- Identify/escalate QC risks and communicate to stakeholders.
Analytical Testing & Documentation
- Ensure compliant QC testing execution for raw materials, intermediates, drug substance, and drug product.
- Oversee timely QC documentation (test methods, protocols, reports, CoAs, quality records).
- Oversee contract labs to ensure on-time delivery and cGMP/data integrity compliance.
- Lead timely resolution of QC testing investigations (root cause, risk assessment, CAPAs).
Compliance & Regulatory Affairs
- Ensure QC compliance with cGMP, FDA, EMA, ICH, and applicable regulations.
- Drive data integrity, documentation, and traceability.
- Draft/review CMC sections and supporting documents; respond to RTQs.
Cross-Functional Collaboration
- Partner with Analytical Development, Manufacturing, QA, Regulatory, and Supply Chain.
- Support technology transfer and method implementation.
- Provide QC input for product development and submission documentation.
Requirements & Qualifications
- 10+ years (BS) OR 8+ years (MS) OR 5+ years (PhD/PharmD) in a related field.
- Hands-on leadership experience in small molecule analytical testing and QC.
- Experience with parenterals, medical device, and combination products.
- Experience establishing analytical specifications; authoring CMC sections.
- Deep understanding of regulatory and phase-appropriate clinical QC expectations.
- Experience managing testing at external labs.
- Strong scientific judgment, communication, cross-functional collaboration, influencing.
- Ability to organize/plan multiple tasks with shifting priorities; think critically/creatively and work independently.
People Leader Accountabilities
- Create Inclusion; Develop Talent; Empower Teams.
Compensation/Benefits (as stated)
- Salary range: $195,670.00–$253,220.00.
- May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits including company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.