Scientist, Biologics CMC Analytical Development

Job Description

Scientist, Biologics CMC Analytical Development
Gilead Sciences (Foster City, CA) isseekinga talented and highly motivatedScientist to join ourPDMPre-Pivotal Biologics AnalyticalDevelopmentgroup. Our collaborative and interdisciplinarydevelopmentteamutilizesstate-of-the-arttechnologies and innovative methodologies to advance medicines into the clinic. The successful candidate is expected toserve as the analyticalleadonPDM (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 CMCAnalyticalTeamforPre‑Pivotal Biologics
  Serve as theCMCanalyticalsub-teamlead to define potential critical quality attributes (pCQAs),establishphase-appropriatecontrol strategies, and enable characterization of biologics supportingToxicology 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 advancedtechnologies (_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 implementstate‑of‑the‑arttechnologies 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/CDMOpartnerships.
• 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 technicalreportsand manuscripts, and support regulatory submissions (_e.g.,_ IND/IMPD/CTA) and intellectual property filings.

Basic Qualifications:

• Ph.D. with 3+ years
• or
• M.S. with6+ years in Analytical Chemistry or related fields,with a focus on biologics(therapeutic proteins)CMCanalytical development.

Preferred Qualifications

• Proven experienceleadingearly-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 diverseperspectives.

Gilead Core Values

• Integrity (Doing What’s Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking PersonalResponsibility)