Principal Scientist, Analytical Lifecycle Management
Gilead Sciences
August 21, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
Principal Scientist, Analytical Lifecycle Management
Job Responsibilities:
- Serve as QC Lead for late-stage clinical biologics programs on cross-functional CMC teams.
- Provide QC leadership, technical direction, and risk-based decision-making to advance biologics drug substance and drug product programs toward late-stage development, registration, and commercialization readiness.
- Own integrated QC strategy across analytical method establishment/qualification/validation, method transfer, specification setting, stability/shelf-life, reference standards, critical reagents, and overall analytical control strategy.
- Lead authorship and technical review for QC-related regulatory submission sections and health authority responses.
- Oversee external partners (CMDOs, CTLs) covering method readiness, testing execution, data quality, investigations, quality events, and alignment with program objectives.
- Anticipate, evaluate, and resolve complex technical, quality, and compliance issues.
- Translate complex QC topics into clear recommendations to drive cross-functional alignment and timely decisions.
- Provide technical mentorship and strategic oversight of lab-based activities as needed.
Requirements:
- PhD in a relevant discipline with 5+ years’ experience; OR Master’s with 8+ years; OR Bachelor’s with 10+ years.
Preferred:
- GMP-regulated biologics QC/analytical development/CMC experience.
- Late-stage biologics QC strategy experience (methods, transfer, specs, stability/shelf-life, reference standards, critical reagents).
- Knowledge of global GMP, ICH, compendial and regulatory expectations.
- Experience authoring/reviewing QC-related regulatory/CMC documentation.
- Ability to influence cross-functional teams and work independently in a matrixed environment.
- Experience overseeing CDMOs/CTLs; excellent written/verbal communication.
- Mandarin speaking/reading preferred but not required.
Benefits:
- Salary range: $195,670.00 - $253,220.00. May include discretionary bonus, long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application instruction:
- Apply via the Internal Career Opportunities portal in Workday.
Job Responsibilities:
- Serve as QC Lead for late-stage clinical biologics programs on cross-functional CMC teams.
- Provide QC leadership, technical direction, and risk-based decision-making to advance biologics drug substance and drug product programs toward late-stage development, registration, and commercialization readiness.
- Own integrated QC strategy across analytical method establishment/qualification/validation, method transfer, specification setting, stability/shelf-life, reference standards, critical reagents, and overall analytical control strategy.
- Lead authorship and technical review for QC-related regulatory submission sections and health authority responses.
- Oversee external partners (CMDOs, CTLs) covering method readiness, testing execution, data quality, investigations, quality events, and alignment with program objectives.
- Anticipate, evaluate, and resolve complex technical, quality, and compliance issues.
- Translate complex QC topics into clear recommendations to drive cross-functional alignment and timely decisions.
- Provide technical mentorship and strategic oversight of lab-based activities as needed.
Requirements:
- PhD in a relevant discipline with 5+ years’ experience; OR Master’s with 8+ years; OR Bachelor’s with 10+ years.
Preferred:
- GMP-regulated biologics QC/analytical development/CMC experience.
- Late-stage biologics QC strategy experience (methods, transfer, specs, stability/shelf-life, reference standards, critical reagents).
- Knowledge of global GMP, ICH, compendial and regulatory expectations.
- Experience authoring/reviewing QC-related regulatory/CMC documentation.
- Ability to influence cross-functional teams and work independently in a matrixed environment.
- Experience overseeing CDMOs/CTLs; excellent written/verbal communication.
- Mandarin speaking/reading preferred but not required.
Benefits:
- Salary range: $195,670.00 - $253,220.00. May include discretionary bonus, long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application instruction:
- Apply via the Internal Career Opportunities portal in Workday.