Principal Scientist, Analytical Operations
Gilead Sciences
August 18, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
Principal Scientist, Analytical Operations (Quality Control Lead) at Gilead
Responsibilities
- Define, implement, and continuously improve QC strategy for small molecule clinical development programs aligned with CMC/quality objectives.
- Lead overall QC activities: method validation/transfer, reference materials, specifications, cGMP release testing, stability strategy/testing, and supervision of external contract labs.
- Manage and approve specifications; establish scientifically sound, phase-appropriate specs aligned with analytical capability, process understanding, and clinical/regulatory expectations.
- Represent QC on cross-functional product development teams and provide technical input for analytical/quality decisions.
- Identify, drive, and escalate improvements and potential QC risks; communicate QC activities, risks, and issues to stakeholders.
- Oversee compliant QC testing for raw materials, intermediates, drug substance, and drug product.
- Ensure timely QC documentation (test methods, protocols, reports, CoAs, quality records) is created, reviewed, and approved.
- Provide oversight to contract testing labs for on-time delivery and cGMP/data integrity compliance.
- Oversee timely resolution of QC testing investigations using root-cause analysis, risk assessment, and CAPAs.
- Ensure QC compliance with cGMP, FDA, EMA, ICH, and applicable regulations; drive data integrity and traceability.
- Serve as QC SME to draft/review CMC sections and supporting documents for regulatory filings and RTQs.
- Partner cross-functionally (Analytical Development, Manufacturing, QA, Regulatory, Supply Chain); support technology transfer and method implementation; provide QC input to submissions.
Qualifications
- 10+ years with a BS OR 8+ years with an MS OR 5+ years with a PhD or PharmD in a related field.
- Significant hands-on leadership experience in small molecule analytical testing and QC.
- Experience establishing analytical specifications and authoring CMC sections.
- Deep understanding of regulatory and phase-appropriate QC for clinical development.
- Demonstrated experience managing external testing laboratories.
- Strong scientific judgment, communication, cross-functional collaboration, and influencing skills.
- Ability to organize/plan multiple tasks amid changing priorities; work independently to determine strategy/resources.
- Knowledge of medical devices and combination products (plus).
Benefits
- Salary range: $195,670.00–$253,220.00; may be eligible for discretionary bonus, stock-based long-term incentives, paid time off, and a benefits package including medical, dental, vision, and life insurance.
Application instructions
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.
Responsibilities
- Define, implement, and continuously improve QC strategy for small molecule clinical development programs aligned with CMC/quality objectives.
- Lead overall QC activities: method validation/transfer, reference materials, specifications, cGMP release testing, stability strategy/testing, and supervision of external contract labs.
- Manage and approve specifications; establish scientifically sound, phase-appropriate specs aligned with analytical capability, process understanding, and clinical/regulatory expectations.
- Represent QC on cross-functional product development teams and provide technical input for analytical/quality decisions.
- Identify, drive, and escalate improvements and potential QC risks; communicate QC activities, risks, and issues to stakeholders.
- Oversee compliant QC testing for raw materials, intermediates, drug substance, and drug product.
- Ensure timely QC documentation (test methods, protocols, reports, CoAs, quality records) is created, reviewed, and approved.
- Provide oversight to contract testing labs for on-time delivery and cGMP/data integrity compliance.
- Oversee timely resolution of QC testing investigations using root-cause analysis, risk assessment, and CAPAs.
- Ensure QC compliance with cGMP, FDA, EMA, ICH, and applicable regulations; drive data integrity and traceability.
- Serve as QC SME to draft/review CMC sections and supporting documents for regulatory filings and RTQs.
- Partner cross-functionally (Analytical Development, Manufacturing, QA, Regulatory, Supply Chain); support technology transfer and method implementation; provide QC input to submissions.
Qualifications
- 10+ years with a BS OR 8+ years with an MS OR 5+ years with a PhD or PharmD in a related field.
- Significant hands-on leadership experience in small molecule analytical testing and QC.
- Experience establishing analytical specifications and authoring CMC sections.
- Deep understanding of regulatory and phase-appropriate QC for clinical development.
- Demonstrated experience managing external testing laboratories.
- Strong scientific judgment, communication, cross-functional collaboration, and influencing skills.
- Ability to organize/plan multiple tasks amid changing priorities; work independently to determine strategy/resources.
- Knowledge of medical devices and combination products (plus).
Benefits
- Salary range: $195,670.00–$253,220.00; may be eligible for discretionary bonus, stock-based long-term incentives, paid time off, and a benefits package including medical, dental, vision, and life insurance.
Application instructions
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.