Principal Scientist, Analytical Ops

Role Summary

Principal Scientist in Biologics Analytical Development (Pivotal and Commercial) at Gilead. Lead rapid testing and the high-throughput analytics team to support process development and product characterization across chromatographic, electrophoretic, and compendial methods. Role involves implementing new technologies, driving data quality and lean data packages, and collaborating across functional areas to enable late-stage biologics programs.

Responsibilities

• Lead a high-throughput testing group to support process development across a wide range of analytical techniques: Chromatographic (SEC, CEX, RPHPLC, HILIC), electrophoretic (CE-SDS, icIEF) and compendial methods (pH, Osmo, subvisible particles, color, etc).
• Manage routine process development and process characterization requests
• Produce high quality, traceable results (ALCOA) for project team process development
• Maintain required personnel to support testing, either via internal hires or through in-source contracting models
• Implement new technologies to improve throughput/quality of data
• Implement agility and refinement of submission processes to achieve lean data packages for rapid decision making
• Implementing rapid testing capabilities at Gilead Foster City site, including instrument set-up/qualification, sample submission process set-up, and personnel hiring/training
• Maintain and manage testing across applicable sites
• Define and manage rapid testing strategies to support process development and process characterization studies, including documentation of data and IQ/OQ commensurate with data use
• Drive continuous improvement of rapid testing to increase throughput and data quality
• Support design/justification/execution of how rapid testing data supports end-to-end control strategy development
• Deliver high quality work packages for supporting pivotal INDa and marketing applications
• Act as analytical project lead for late-phase program overseeing all analytical deliverables
• Author and review CMC sections in regulatory filings; support interactions with health agencies
• Collaborate across PDM and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development
• Shape late-stage development strategies as a member of the extended Analytical Development leadership team
• Demonstrate knowledge in analytical CMC areas including CQAs, separations, method bridging, reference standards, comparability, and specifications
• Adopt novel characterization technologies and approaches
• Recruit, hire, and mentor talent to cultivate a world-class Biologics AD organization

Qualifications

• Basic Qualifications:
  • 10+ years with BS, or
  • 8+ years with MS, or
  • 5+ years with PhD/PharmD, or
  • 2+ years with MD
• Preferred Qualifications:
  • PhD with 8+ years or MS with 10+ years in Analytical Chemistry or related fields with people leader accountabilities
  • Significant expertise in rapid testing instrumentation, automation and data processing
  • Experience with MS, AUC, SEC, RP, IEX, CGE, DLS, MALS and related analytical technologies
  • Subject matter expert in biologics control strategies
  • FDA/ICH guidance knowledge related to drug substance/product; experience drafting IND/BLA/PAS
  • Strong collaboration across CMC functions; business acumen; resource/budget/program management
  • Knowledge of lab automation, computer validation, data governance, data science, knowledge management
  • Leadership attributes: collaboration, team development, accountability, cross-functional engagement, strategic vision

Education

• Doctoral or Master's degree in Analytical Chemistry or related field; industry experience in biologics analytical development and/or structural characterization preferred

Additional Requirements

• Ability to lead across multiple sites and functions; travel as needed to support program goals