Director, Cell Culture Process Development – Pivotal & Commercial Biologics

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Job Description
 

Director, Cell Culture Process Development – Pivotal & Commercial Biologics

The Director of Cell Culture Process Development for Pivotal and Commercial Biologics will be responsible for leading the development and characterization of cell culture processes for multiple biologics programs during the Pivotal and Commercial stages. This responsibility will also include post launch Life Cycle Management (LCM) development activities and regulatory strategy for Gilead’s biologics entities. This role is expected to work collaboratively with cross-functional stakeholders and contribute to the overall biologics CMC development strategies.

Responsibilities:

• Provide leadership and oversight for multiple pivotal and/or commercial biologic programs.
• Accountable for development and characterization of robust cell culture processes to support Pivotal clinical and Commercial manufacturing, including Life Cycle Management. This includes accountability for developing an integrated control strategy in partnership with organizations across Technical Development, Quality, Regulatory Affairs CMC, and Manufacturing.
• Lead efficient cell culture process development and transfer to internal and contract manufacturing facilities to produce GMP and non GMP drug substances on time and with high success rate. Oversee data generation/data integrity to ensure compliance. Lead manufacturing atypical event investigations.
• Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections.
• Ensure strong relationships with key stakeholder functions including other Biologics Technical Development functions, Research, Clinical Development, and Clinical Supply Management and Product Strategy Teams by providing technical and strategic input.
• Demonstrate a knowledge of the cGMP practices and compliance requirements.
• Contribute to defining the strategy toward the next generation Gilead biologics platform. Partner with stakeholders in other functional area to lead projects toward development of the next generation platform.
• Drive development and implementation of new process technologies to meet business and portfolio needs.
• Remain current on trends and new technology advancements across the Biopharmaceutical industry.
• Hire, mentor and develop team members within the organization to help build and grow a world-class biologics cell culture process development organization.

Qualifications:

• Ph.D. in Chemical Engineering, Biochemistry, or related fields with 8+ years’ experience OR M.S. with 10+ years’ experience OR