Associate Scientist - Method Development, Analytical Operations
Associate Scientist, Method Development, Analytical Operations – Foster City, California
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the Pharmaceutical Development & Manufacturing (PDM) workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
Gilead Sciences is currently seeking an Associate Scientist to join the Analytical Operations department. The Associate Scientist will develop and execute analytical methods to support the characterization of drug substances and drug products during clinical development. The Associate Scientist will support analytical development, process research, formulation development, and assist in regulatory filings.
Job Responsibilities:
- Develop analytical test methods for small molecule to support development activities on drug substances and biologics, solid dosage form and parenteral/injectable drug products (purity/impurity by LC, water content determination, dissolution, particulate matter, sterility etc.)
- Plan schedules and arranges own activities in accomplishing programs goals
- Selects appropriate methods and techniques to support development programs.
- Collaborates with supervisory personnel and lab analysts to develop methods.
- Performs physical and chemical characterization of drug substances for biologics, solid dosage form and parenteral drug products (thermal analysis, particle size, microscopy, XRPD, etc.).
- Troubleshoots analytical methods and lab instrumentation.
- May investigate root causes of atypical results and propose corrective actions
- Recommends alternatives, researches new methods and techniques and may proactively seek out senior personnel to discuss potential solutions to problems.
- Processes and interprets data. Presents findings at group meetings and technical seminars.
- Uses good verbal communication and interpersonal skills to provide insight into the processes used to achieve results of assigned tasks.
- Accurately and timely documents work in laboratory notebooks, logbooks, and laboratory software,
- Works cross-functionally with process chemistry, formulations development, analytical method validation, release and stability groups by representing group as a prime contact person to develop drug candidates
- Authors reports, protocols, test methods, and other documentation.
- Trains others in execution of analytical test methods or analytical techniques.
Education and Experience:
- Bachelor’s with 5+ years of relevant biotech/pharmaceutical professional experience, OR master’s degree with 3+ years of relevant biotech/pharmaceutical professional experience. Degrees should be in Analytical Chemistry, Organic Chemistry, Biochemistry, Biology or a related discipline from an accredited university.
- Strongest consideration will be given to candidates with demonstrated experience in biologics and parenteral drug product development.
- Hands-on proficiency and problem-solving skills with HPLC/UPLC, GC or other chromatographic techniques. Familiarity with spectroscopic techniques, chromatographic separations (RPLC, SEC, Ion exchange, chiral), parenteral characterization (osmolality, subvisible particles, pH, extractable volume, etc.) and solid-state characterization (FTIR, XRPD, DSC, TGA, PSD) is an advantage.
- Strong verbal and written communication skills.
To apply, please submit resume through our website at www.gilead.com
Gilead is an equal opportunity employer.