Sr Research Associate II, Analytical Operations (Open)
Senior Research Associate II, Analytical Outsourcing & Stability (AOS)
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 successful candidate will possess a detailed understanding of analytical method development, strong critical thinking skills, and excellent communication skills.
Specific Responsibilities
- 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) in collaboration with supervisory personnel and lab analysts using techniques such as liquid chromatography, Karl-Fischer, dissolution, disintegration.
- Troubleshoot instrumentation and test methods.
- Review testing data and results to ensure compliance to appropriate test methods, specifications, and protocols. Recognize anomalous and inconsistent results and interpret outcomes.
- Participate in method validation and method transfer to QC and external laboratories.
- Author and revise analytical methods, specifications, protocols, reports, and other documentation.
- Able to work well independently and in a team setting on assigned tasks, such as method development and stability testing.
- Participate in group meetings, present results of work, interpret data, and draw conclusions regarding presented material and nature of work.
- Work in collaboration to design experiments and advance state-of-the-art techniques.
- Recommend alternatives, research new methods and techniques, and proactively seek out senior personnel to discuss potential solutions to problems.
- Use good verbal communication skills and interpersonal skills to provide insight into the processes used to achieve results of assigned tasks.
Key Knowledge & Skills
- Excellent communication skills (both verbal and technical) and interpersonal skills required.
Education & Experience
- A Bachelor’s Degree in Analytical Chemistry, Organic Chemistry, Biochemistry, or a related discipline with a minimum of four (4) years of relevant biotech/pharmaceutical professional experience, OR a Master’s Degree in Analytical Chemistry, Organic Chemistry, Biochemistry, or a related discipline with a minimum of two (2) years of relevant biotech/pharmaceutical professional experience.
- Hands-on experience and problem-solving skills with chromatographic techniques (HPLC/UPLC, GC) and dissolution.
About Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.