Principal Scientist, Analytical Operations

Responsibilities

• Provide strategic oversight and operational execution of cGMP analytical testing for small molecule clinical development programs.
• Serve as the Quality Control (QC) lead, defining and improving QC strategies in alignment with CMC and quality objectives.
• Manage and approve specifications, collaborating cross-functionally to ensure they are scientifically sound and phase-appropriate.
• Oversee QC testing for raw materials, in-process materials, intermediates, drug substance, and drug product.
• Direct the resolution of QC testing investigations, including root-cause analysis, risk assessment, and CAPA implementation.
• Manage analytical technology transfer activities to contract manufacturing organizations (CMOs) and provide oversight to external laboratories.
• Act as a QC subject matter expert for drafting and reviewing CMC sections of regulatory filings and responding to regulatory inquiries.

Requirements

• PhD in chemistry or a related area with 5+ years of relevant experience, OR
• MA/MS in chemistry or a related area with 8+ years of relevant experience, OR
• BA in chemistry or a related area with 10+ years of relevant experience.
• Deep technical expertise in analytical chemistry.
• Strong knowledge of cGMP operations and regulatory requirements (FDA, EMA, ICH).

Preferred Qualifications

• 10+ years of hands-on and leadership experience in small molecule pharmaceutical analytical testing and quality control.
• Experience establishing analytical specifications and authoring CMC sections for regulatory submissions.
• Demonstrated experience managing testing activities at external testing laboratories and CMOs.
• Strong scientific judgment and the ability to lead cross-functional teams.
• Knowledge of medical devices and combination products.

About the Company

Gilead is a research-based biopharmaceutical company that has tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer for more than 35 years. We work relentlessly to develop therapies that improve lives and ensure global access to life-changing scientific innovations.