Scientist, Analytical Operations | Foster City, California – Process/Product Development & Operations
Department: Process/Product Development & Operations
Employment Type: Full-Time
Location: Onsite
About Gilead Sciences:
Gilead Sciences is a global biopharmaceutical leader committed to creating a healthier world. For over 35 years, Gilead has advanced therapies for HIV, viral hepatitis, COVID-19, and cancer, delivering life-changing medicines and ensuring global access.
Position Overview:
Gilead is seeking a highly skilled Scientist in Analytical Operations to join our Pre-Pivotal Biologics Analytical Development team. The ideal candidate will serve as the analytical lead on Pharmaceutical Development & Manufacturing (PDM) projects, driving analytical characterization, method development, and regulatory compliance for biologic molecules in pre-pivotal stages (Toxicology, Phase I/II).
Key Responsibilities:
Lead analytical characterization and method development for pre-pivotal biologic molecules.
Identify critical quality attributes and propose analytical control strategies; author regulatory filings for biologic drug substance and product.
Develop advanced characterization methods using mass spectrometry (Native LC-MS, CE-MS, MD-LC-MS, affinity LC-MS, automated high-throughput LC-MS/MS).
Implement and validate analytical methods (HPLC-UV, HPLC-FLR, CE, iCIEF, HPLC-CAD, etc.) and author associated reports, test procedures, and protocols.
Evaluate and implement cutting-edge technologies to drive innovation in analytical development.
Oversee data integrity and analytical compliance for both internal and outsourced testing.
Collaborate cross-functionally with Research, Clinical Development, Clinical Supply Management, and Program Strategy teams.
Provide technical support to internal and external cGMP manufacturing operations.
Prepare research reports, peer-reviewed manuscripts, IND submissions, and patent filings.
Qualifications:
Ph.D. with 3+ years or M.S. with 6+ years of industrial experience in Analytical Chemistry or related biologics analytical development.
Expertise in LC-MS based biologics characterization and data analysis to support CMC process development.
Hands-on experience in analytical method development, validation, and control strategies (HPLC, CE-SDS, iCIEF, LC-MS/MS, gel electrophoresis).
Familiarity with FDA and ICH guidelines for drug substance and product registration, quality, and compliance.
Strong collaboration skills with other CMC and cross-functional teams.
Knowledge of lab automation, computer validation, data governance, data science, and knowledge management.
Gilead Core Values:
Integrity: Doing what’s right.
Inclusion: Encouraging diversity.
Teamwork: Working together.
Excellence: Being your best.
Accountability: Taking personal responsibility.
Compensation & Benefits:
Salary Range: $146,540 – $189,640
Eligible for discretionary annual bonus, stock-based incentives, paid time off, and comprehensive benefits including medical, dental, vision, and life insurance plans.
Equal Opportunity Employer:
Gilead Sciences is committed to fostering an inclusive, discrimination-free environment. Reasonable accommodations are provided to applicants with disabilities.
Job Requisition ID: R0048995
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