Head of Cell Therapy Technical Operations, Vice President

Responsibilities

• Own and provide technical guidance, strategic direction, and long-range planning in the execution of all CMC (Chemistry, Manufacturing and Controls) and related activities through BLA and commercial sales
• Lead cell therapy manufacturing, including all CMC functional areas – QA, QC, MSAT, GMP Manufacturing, Commercial Assay Validation
• Establish the requirements for the commercial manufacturing process, coordinating technical transfers to manufacturing and between sites, developing process qualification, process control, and comparability strategies, and supporting the authoring of technical sections of major regulatory documents.
• Contribute to strategic discussions for the overall Chemistry, Manufacturing, and Controls (CMC) and commercial strategy.
• Ongoing technical oversight of manufacturing, defining and driving a long-term process improvement lifecycle plan, and ensuring the successful execution of the technical strategy.
• Work cross-functionally across technical operations and closely with external Integrated Drug Manufacturing Organizations (IDMOs)
• Supervisory responsibilities for a technical team, driving technology transfer, validation, qualification, and comparability strategies while being recognized as a technical thought leader in cell therapy drug product manufacturing technology.
• Provide technical content for significant documents such as tech transfer plan/report, PPQ or comparability assessments, and author content for regulatory submissions.
• Own the technology transfer of the commercial assets including ownership of the tech transfer plan and final report.
• Develop product technical strategies including manufacturing requirements and process improvement plans as part of the technology transfer.
• Define the post-approval life cycle management plans and ensure successful and timely execution working across functional groups.
• Function as a subject matter expert for autologous T cell therapies and manufacturing technologies.
• Derive motivation from working in a small, entrepreneurial biotech environment, accepting the challenge of broad responsibilities and opportunities within a fast-paced, matrix-focused can-do culture.
• A “hands-on” operational approach and ability to deliver on corporate goals integrating internal and external, virtual resources lay at the core of this role.

• Multi-year experience encompassing the above

• Job Type: Full-time
• Experience:
  
  Pharma or CAR-T