Executive Director, Purification Process Development – Pivotal & Commercial Biologics

Executive Director, Purification Process Development leads late-stage purification and conjugation process development and characterization for biologics from pivotal through commercial launch, including post-launch lifecycle management. Sets strategy and provides technical leadership across cross-functional partners to deliver robust processes, effective control strategies, and successful clinical/commercial tech transfers and filings.

Key Responsibilities:
- Lead Biologics Purification Process organization.
- Accountable for development, characterization, and clinical tech transfer of purification processes to support Pivotal clinical and Commercial manufacturing, including LCM; develop an integrated control strategy.
- Support CMC regulatory filings (draft/review/approval of CMC sections), agency interactions, and product-related inspections.
- Partner across PDM (Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Finance, Technical Development) to ensure successful commercialization and on-time product delivery.
- Provide technical/strategic input to Research, Clinical Development, and Gilead Asset Teams.
- Demonstrate knowledge of cGMP and compliance requirements.
- Serve on Biologics Pivotal/Commercial Technical Development Leadership Team to develop late-stage strategy.
- Drive development/implementation of new process technologies; remain current on industry trends.
- Assist with due diligence for asset purchases and partnership opportunities.
- Set goals aligned to portfolio/functional priorities; hire, mentor, and develop team; develop/manage department budget.

Required Skills/Qualifications (as stated):
- Bachelor’s (14 years) OR Masters (12 years) OR PhD (12 years).
- Extensive hands-on purification process development; integrated purification development/scale-up (harvest, chromatography resin/membrane, filtration); design for viral clearance; conjugation process experience required.
- Control strategy deployment; IND/BLA/MAA regulatory section generation experience.
- Success in multidisciplinary, highly matrixed environment; ability to build high-performing teams.
- Excellent decision-making and written/verbal communication; strong leadership/influencing/collaboration; scientific eminence.

Application instructions:
- For current Gilead employees and contractors, apply via the Internal Career Opportunities portal in Workday.