Scientist, Biologics CMC Analytical Development
About The Position
Gilead Sciences (Foster City, CA) is seeking a talented and highly motivated Scientist to join our PDM Pre-Pivotal Biologics Analytical Development group. Our collaborative and interdisciplinary development team utilizes state-of-the-art technologies and innovative methodologies to advance medicines into the clinic. The successful candidate is expected to serve as the analytical lead on PDM (Pharmaceutical Development & Manufacturing) project teams. You will have opportunities for career growth through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment.
Requirements
- Ph.D. with 3+ years or M.S. with 6+ years in Analytical Chemistry or related fields, with a focus on biologics (therapeutic proteins) CMC analytical development.
- Proven experience leading early-stage CMC analytical programs, supporting pre-pivotal development (Toxicology, Phase I/II) and regulatory submissions (IND/IMPD).
- Strong experience in analytical method development, qualification/validation, and control strategy for biologics (e.g., HPLC, iCIEF, CE, LC‑MS based biologics characterization and data analysis).
- Working knowledge of FDA/ICH regulatory expectations for drug substance and drug product quality and compliance.
- Demonstrated ability to collaborate effectively across CMC and cross‑functional teams.
- Familiarity with digital and data capabilities, including lab automation, data governance, computer system validation, and knowledge management.
- Commitment to fostering inclusive, high‑performing teams, recognizing the value of diverse perspectives.
Responsibilities
- Lead CMC Analytical Team for Pre‑Pivotal Biologics: Serve as the CMC analytical sub-team lead to define potential critical quality attributes (pCQAs), establish phase-appropriate control strategies, and enable characterization of biologics supporting Toxicology and early clinical development (Phase I/II).
- Drive Analytical Method Development & Implementation: Design, develop, and deploy robust analytical methods for product characterization and release/stability testing using advanced technologies (e.g., HPLC-UV/FLR/CAD/ELSD, CE/iCIEF, Native LC-MS, CE-MS, MD-LC-MS, affinity LC-MS). Author method development reports, test procedures, and associated technical documentation.
- Advance Innovation in Analytical Development: Evaluate and implement state‑of‑the‑art technologies and emerging approaches to enhance analytical capabilities, improve efficiency, and enable deeper molecular understanding.
- Ensure Data Integrity and Operational Excellence: Provide technical oversight of internal and external analytical activities, ensuring high-quality data generation, compliance with regulatory expectations, and strong data governance across CRO/CDMO partnerships.
- Collaborate Cross‑Functionally to Drive Program Success: Partner closely with Research, Process Development, Clinical Development, Safety, and Program Strategy teams to provide strategic and technical input across the product lifecycle.
- Contribute to Regulatory and Scientific Deliverables: Present findings to senior leadership, author technical reports and manuscripts, and support regulatory submissions (e.g., IND/IMPD/CTA) and intellectual property filings.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
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What This Job Offers
Job Type
Full-time
Career Level
Senior
