Scientist, FPD

Responsibilities

• Provide formulation, process, and manufacturing support and technical expertise throughout the R&D lifecycle, from pre-exploratory stages to commercialization.
• Design and execute experiments to support drug substance and drug product development.
• Troubleshoot analytical methods, instrument operation, and manufacturing processes.
• Develop and optimize manufacturing processes and control strategies.
• Perform drug substance, drug product intermediate, and drug product characterization.
• Assist in the preparation and review of GMP documentation and author technical reports for regulatory submissions (IND, IMPD, NDA).
• Oversee the manufacture of GMP clinical and/or development drug product batches.
• Maintain laboratory functions and ensure compliance with EHS and safety protocols.

Requirements

• 6+ years of experience with a BS degree, 4+ years with an MS degree, or a PhD in a related scientific discipline.
• Proven expertise in small molecule formulation.
• Experience with GMP documentation and regulatory standards.
• Proficiency in analytical method troubleshooting and laboratory instrumentation.

Preferred Qualifications

• 11+ years of experience with a BS degree in a related scientific discipline.
• 9+ years of experience with an MS degree in a related scientific discipline.
• Ability to work independently on complex problems requiring comprehensive evaluation of multiple factors.
• Experience with tech transfer and scale-up at internal and external manufacturing sites.

About the Company

Gilead Sciences 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 are dedicated to developing life-changing therapies and ensuring global access to improve lives worldwide.