Executive Director of Analytical Development

5 hours ago

Foster City, California, United States Gilead Sciences, Inc. Full time

About the Role

The Executive Director of Analytical Development will lead the analytical development team, overseeing method development, qualification, and molecule characterization for biologics programs during the Pivotal and Commercial phases. This role will play a key part in post-launch Life Cycle Management and will be an integral member of the Pivotal/Commercial Biologics Technical Development Leadership Team.

Key Responsibilities

  • Provide strategic leadership to the Pivotal & Commercial Biologics Analytical Development team.
  • Accountable for developing analytical control strategies and regulatory strategies for drug substance and drug product quality attributes.
  • Develop and implement analytical testing plans for drug substance and drug product development.
  • Guide the draft, review, and approval of CMC sections in regulatory filings and support agency interactions and inspections.
  • Collaborate with cross-functional teams to ensure timely delivery and successful commercialization of late-stage portfolio.
  • Foster relationships with functions like Research, Clinical Development, and Product Strategy Teams.
  • Exhibit comprehensive knowledge of cGMP practices and requirements.
  • Act as a key member of the Biologics Technical Development Leadership Team to shape late-stage Biologics strategy.
  • Pioneer the adoption of novel process technologies.
  • Stay updated on Biopharmaceutical industry trends.
  • Set organizational goals that align with broader objectives.
  • Recruit, mentor, and nurture talent to cultivate a world-class Biologics AD organization.
  • Oversee departmental budgeting.

Qualifications

  • A Ph.D. or M.S. in a relevant field with 15+ years in analytical development, showcasing increasing responsibility and comprehensive experience managing programs from INDs to MAAs.
  • Subject matter expert in MOA for defining CQAs and QbD-based control strategies.
  • Comprehensive product quality control strategies for biopharmaceutical processes.
  • Development/Qualification/Validation of various assays, including Product purity, process-related impurities, and cell-based potency.
  • Product characterization techniques, including both biophysical and potency-based methods.
  • High-throughput assay methodologies.
  • Well-acquainted with industry best practices, guidelines, and trends.
  • Proven track record in drafting regulatory documentation of all stages, including IND, BLA, and MAA filings.
  • Effective team builder with proven leadership in a multidisciplinary setting.
  • Outstanding communication, decision-making, and interpersonal skills.
  • Demonstrated ability to influence and shape industry standards with a notable presence in the scientific community.

About Gilead Sciences, Inc.

Gilead Sciences, Inc. is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. We are committed to making a difference in the lives of people with life-threatening diseases around the world.

Benefits

Gilead Sciences, Inc. offers a comprehensive benefits package, including medical, dental, vision, and life insurance plans, as well as a 401(k) plan and paid time off. Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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