Executive Director, Analytical Development – Pivotal & Commercial Biologics

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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

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Job Description
 

The Executive Director of Analytical Development (AD) will spearhead the analytical development encompassing method development, qualification, and molecule characterization for all biologics programs during the Pivotal and Commercial phases. They will play an instrumental role in post-launch Life Cycle Management (LCM) and will be an integral member of the Pivotal/Commercial Biologics Technical Development Leadership Team.

This team oversees late-stage process development activities, including Cell Culture, Purification, Formulation & Process Development, Analytical Development, MSAT, and Materials Sciences.

Responsibilities:

• Provide leadership to the Pivotal & Commercial Biologics Analytical Development team.

• Accountable for:

  • Methods: Including development, QC support, validation, remediation, and LCM.

  • Developing Analytical control strategies and regulatory strategies for drug substance and drug product quality attributes.

  • Analytical target profiles, including method criteria

  • Molecule characterization to define CQAs and develop phase appropriate QTPP targets for DS & DP development.

  • Analytical testing for DS & DP development.

• Guide the draft, review, and approval of CMC sections in regulatory filings, and support agency interactions and inspections.

• Collaborate across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Finance and Technical Development to ensure timely delivery and successful commercialization of late-stage portfolio.

• Foster robust relationships with functions like Research, Clinical Development, and Product Strategy Teams while proving technical and strategic input. 

• 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, balancing immediate and long-term priorities.

• 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 a