Principal Scientist, Analytical Lifecycle Management

Responsibilities

• Serve as the Quality Control (QC) lead for late-stage clinical biologics programs, acting as the primary strategic point of contact on cross-functional CMC teams.
• Drive integrated QC program strategies, including analytical method establishment, qualification, validation, method transfer, and specification setting.
• Lead the authorship and technical review of QC-related sections for regulatory submissions and health authority responses.
• Provide oversight of external partners, such as CDMOs and Contract Testing Laboratories, ensuring data quality and alignment with program objectives.
• Resolve complex technical and compliance issues using risk-based decision-making and scientific judgment.
• Provide technical mentorship and guidance to matrixed colleagues to foster scientific rigor and high-quality execution.

Requirements

• PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, Biological Sciences, or a related scientific discipline with 5+ years of relevant experience; OR
• Master’s Degree in a related scientific discipline with 8+ years of relevant experience; OR
• Bachelor’s Degree in a related scientific discipline with 10+ years of relevant experience.
• Experience in Quality Control, Analytical Development, or CMC technical roles.
• Knowledge of GMP and ICH guidance.

Preferred Qualifications

• Extensive experience supporting biologics drug substance and/or drug product programs in a GMP-regulated environment.
• Demonstrated expertise in late-stage biologics QC strategy, including stability, shelf-life justification, and reference standards.
• Proven ability to influence senior stakeholders and communicate complex technical topics to cross-functional teams.
• Experience overseeing external partners such as CDMOs and CTLs.
• Ability to speak and read Mandarin is a plus.

About the Company

Gilead is a research-based biopharmaceutical company that is committed to creating a healthier world for all people. For more than 35 years, we have tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer, working relentlessly to develop therapies that improve lives and ensure global access.