Scientist, Biologics CMC Analytical Development

Job Description Scientist, Biologics CMC Analytical Development 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.

• Ph.D. with 3+ years of experience in analytical chemistry or related field.
• M.S. with 6+ years in analytical chemistry or related fields, focusing 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.

The salary range for this position is $ – $. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Appli for assistance.