Sr. Research Associate I, 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 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 and parenteral 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.
Supports drug substance and drug product stability studies and routine sample analysis.
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 group meetings, present results of work, interpret data, and draw conclusions regarding presented material and nature of work.
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.
Education & Experience:
Minimum Master’s degree with 2+ years of relevant biotech/pharmaceutical professional experience; or Bachelor’s with 4+ years of relevant biotech/pharmaceutical professional experience.
Degrees should be in analytical chemistry, organic chemistry, pharmaceutical sciences, or a related discipline from an accredited university.
Preferred candidate with a Master’s degree with 3+ years of relevant biotech/pharmaceutical professional experience; or Bachelor’s with 5+ years of relevant biotech/pharmaceutical professional experience.
Hands-on experience in small molecule method development following USP guidelines for HPLC/UPLC, GC, and dissolution is an advantage.
Foster City, CA
Gilead Sciences, Inc., a research-based biopharmaceutical company, discovers, develops, and commercializes medicines in the areas of unmet medical needs in the United States, Europe, and internationally. The company’s products include Biktarvy, Descovy, Odefsey, Genvoya, Stribild, Complera/Eviplera, Atripla, and Truvada for the treatment of human immunodeficiency virus (HIV) infection in adults; and Vosevi, Vemlidy, Epclusa, Harvoni, and Viread products for treating liver diseases.
It also provides Yescarta, a chimeric antigen receptor T cell therapy for adult patients with relapsed or refractory large B-cell lymphoma; Zydelig, a kinase inhibitor; Letairis, an oral formulation of an endothelin receptor antagonist for pulmonary arterial hypertension; Ranexa, a tablet to treat chronic angina; and AmBisome, an antifungal agent to treat serious invasive fungal infections. In addition, the company offers its products under the name Cayston, Emtriva, Hepsera, Sovaldi, and Tybost. Further, it develops product candidates for the treatment of HIV/AIDS and liver diseases, hematology/oncology, inflammation/respiratory diseases, and others.
The company markets its products through its commercial teams; and in conjunction with third-party distributors and corporate partners. Gilead Sciences, Inc. has collaboration agreements with Bristol-Myers Squibb Company; Janssen Sciences Ireland UC; Japan Tobacco Inc.; Galapagos NV; Scholar Rock Holding Corporation; Tango Therapeutics; National Cancer Institute; Pfizer, Inc.; Sangamo Therapeutics, Inc.; Gadeta B.V.; HiFiBiO Therapeutics; Agenus Inc.; HOOKIPA Pharma Inc.; Goldfinch Bio, Inc.; and insitro Inc. The company was founded in 1987 and is headquartered in Foster City, California.