Scientist, Analytical Ops

Role Summary

Gilead Sciences (Foster City, CA) is seeking a talented and highly motivated Scientist to join our Pre-Pivotal Biologics Analytical Development group. The successful candidate will serve as the analytical lead/representative on Pharmaceutical Development & Manufacturing project teams and will have opportunities for career growth in a fast-paced, resource-rich environment. The role involves advancing medicines into the clinic through collaborative, interdisciplinary development and analytical strategies.

Responsibilities

• Lead and support analytical characterization activities for pre-pivotal (Toxicology, Phase I/II) biologic molecules. Identify molecule critical quality attributes, propose and justify analytical control strategies, and author relevant regulatory filings for biologic drug substance and drug product.
• Lead the development of advanced extended characterization methods utilizing state-of-the-art mass spectrometry technologies including Native LC-MS, CE-MS, MD-LC-MS, affinity LC-MS, and automated high-throughput LC-MS/MS for pre-pivotal biologics.
• Develop analytical methods for molecule characterization and/or release testing (using HPLC-UV, CE, HPLC-FLR, iCIEF, HPLC-CAD, etc.). Author method development reports, test procedures, validation protocols and reports.
• Proactively evaluate and implement state-of-the-art technologies to drive innovation in Analytical Development and testing.
• Oversee and advise data generation / data integrity and ensure compliance and analytical excellence from internal and outsourced testing at contract organizations.
• Maintain strong relationships with key stakeholder functions and work cross-functionally with colleagues in Research, Clinical Development, and Clinical Supply Management and Program Strategy Teams by providing technical and strategic input.
• Provide technical support to internal and external cGMP manufacturing operations.
• Present research findings and recommendations to senior staff, prepare research reports and peer-reviewed manuscripts, and contribute to the preparation of INDs and patent filings.

Qualifications

• Ph.D. with 3+ years or M.S. with 6+ years in Analytical Chemistry or related fields of industrial experience in biologics analytical development.
• Advanced expertise and hands-on experience with LC-MS based biologics characterization and data analysis to support CMC process development.
• Experience with analytical method development, validation, and control strategies of biologic products (e.g., HPLC, CE-SDS, iCIEF, LC-MS/MS, intact/reduced/sub-units mass, gel electrophoresis, etc).
• Familiar with FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product.
• Ability to build strong collaborations with other CMC functions.
• Working knowledge of lab automation, computer validation, data governance, data science, knowledge management and data protection.
• Commitment to inclusion and diversity in team management and collaboration.

Skills

• LC-MS based biologics characterization and data analysis
• Analytical method development, validation, and control strategy design for biologics
• Mass spectrometry technologies such as Native LC-MS, CE-MS, MD-LC-MS, affinity LC-MS, and high-throughput LC-MS/MS
• Data integrity, regulatory filings, and cross-functional collaboration

Education

• Ph.D. in Analytical Chemistry or related field (or M.S. with substantial industrial experience in biologics analytical development)