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 T oxicology and early clinical development (Phase I/II).
• Drive Analytical Method Development & Implementation
• 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.

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 exp erience l ead ing early-stage CMC analytical programs, supporting pre-pivotal development ( T oxicology, 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)
• The salary range for this position is: $146,540.00 - $189,640.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be elig

Benefits

Additional Information

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description 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 team s . You will have opportunities for career growth through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Gilead Sciences? Share your experience