Research Scientist
Specific Responsibilities & Skills for the Position:
- Partner with Process Chemistry, QA and other groups within Analytical Operations.
- Leading teams developing analytical specifications and methods and supporting clinical small molecule process development and manufacturing.
- Provide technical and regulatory support to drug substance development, including impurity control strategies and process route development.
- Accountable to summarize studies, generate, review and approve necessary reports to provide scientifically sound and data-based support of product development.
- Facilitate method transfer to other Gilead sites and CTLs/CMOs as guided by project requirements.
- Provide the highest quality analytical support, meet ambitious timelines and ensure compliance to SOPs, protocols, cGMPs and safety regulations
- Support analytical characterization of small molecule, antibody-drug conjugate processes and contribute to development of impurity control strategies
- Apply relevant regulatory guidance (USP, ICH, CFR) in daily work and work planning
Essential Education & Skills:
- Ph.D. in Chemistry or BS/MS with extensive industry experience
- A strong chemist who leads with data and understands the requirements for process development and GMP manufacturing.
- Familiarity with physical and chemical characterization of drug substances and drug substance intermediates.
- Knowledge in analytical and organic chemistry and experience in development and quality control in a highly regulated environment
- Excellent written and verbal communications skills required
- Comfort working in multi-disciplinary teams, learning new skills and proactively solving problems