Scientist, Biologics CMC Analytical Development

Scientist, Biologics CMC Analytical Development

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.

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.

Basic Qualifications:

• 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.

Preferred Qualifications

• 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.

Gilead Core Values

Integrity (Doing What’s Right)

Inclusion (Encouraging Diversity)

Teamwork (Working Together)

Excellence (Being Your Best)

Accountability (Taking Personal Responsibility)