Gilead Sciences · 1 day ago
Scientist, Analytical Ops
San Francisco Bay Area
Full-time
Onsite
Mid, Senior Level
$147K/yr - $190K/yr
3+ years expGilead Sciences is committed to creating a healthier world and is seeking a talented Scientist to join their Pre-Pivotal Biologics Analytical Development group. The role involves leading analytical characterization activities for biologics and developing advanced characterization methods, contributing to the advancement of medicines into the clinic.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
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, 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 (but not limited to) Native LC-MS, CE-MS, MD-LC-MS, affinity LC-MS, and automated high-throughput LC-MS/MS, for pre-pivotal (Phase I/II) biologics
Develop analytical methods to be used for molecule characterization and/or release testing (using HPLC-UV, CE, HPLC-FLR, iCIEF, HPLC-CAD, etc.). Author associated 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
Presents research findings and recommendations to senior staff, prepare research reports and peer-reviewed manuscripts, and contribute to the preparation of INDs, and patent filings
Qualification
Required
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 of building strong collaborations with other CMC functions
Working knowledge of lab automation, computer validation, data governance, data science, knowledge management and data protection
Create Inclusion - knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the way they manage their teams
Benefits
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2026-01-13
Company data provided by crunchbase