Associate Scientist, Analytical Ops
Associate Scientist, Analytical Operations
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines. 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.
This role is in the Analytical Core Team (ACT) within Analytical Operations (AO), based at our headquarters in Foster City, CA. The group is responsible for CMC analytical activities related to the development of Gilead’s small molecule drug substances and drug products. The Associate Scientist will develop and execute analytical methods to support analytical and formulation development. The successful candidate will possess a detailed understanding of analytical method development, strong critical thinking skills, and excellent communication skills.
Essential Responsibilities & Skills:
- Develop and execute analytical methods related to solid oral dosage drug product (stability-indicating assay and impurities, discriminatory dissolution, blend and content uniformity, water content) using techniques such as liquid chromatography, Karl-Fischer, dissolution, disintegration to support analytical and formulation development.
- Use computational predictive tools and modelling software to aid method development.
- Conduct studies for method development/evaluation, validation, transfer and verification according to scientific justifications and current regulatory guidance (e.g., ICH, FDA, USP, EP, etc.).
- Plan and execute experiments such as stability studies, process and formulation samples that support development activities and project goals.
- Troubleshoot analytical methods and lab instrumentation.
- Process and interpret data. Present findings and conclusions at group meetings and technical seminars.
- Recommends and explore alternatives, researches new methods and techniques and proactively seek out senior personnel to discuss potential solutions to problems.
- Author technical documents, including validation/transfer/verification protocols and reports, analytical test procedures, technical reports, analytical investigations, and other documentation.
- Collaborate with supervisory personnel and lab analysts to plan experiments, and work cross-functionally with formulation development, analytical method validation, release and stability groups.
- Develop subject matter expertise in an analytical technique and acts as a resource for other employees within the department.
- Use good verbal and written communication skills and interpersonal skills to provide insight into the processes used to achieve results of assigned tasks.
Education & Experience:
- MS degree with 6+ years OR BS degree with 8+ years of relevant biotech/pharmaceutical professional experience. Degrees should be in Analytical Chemistry, Organic Chemistry, Biochemistry, or a related discipline.
- Hands-on experience and problem solving skills with chromatographic techniques (HPLC/UPLC and GC) and dissolution.
- Experience with mass spectrometry preferred.
To apply, please submit resume through our website at www.gilead.com
Gilead is an equal opportunity employer.