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Head of Technology Transfer Operations

2 months ago

Cambridge, Massachusetts, United States BioTalent Full time

Position Overview: We are collaborating with a dynamic cell therapy organization to identify a Director of Tech Transfer who will spearhead initiatives aimed at enhancing the efficiency of Tech Transfer processes and optimizing overall operational effectiveness.

Key Responsibilities:

  • Oversee the Operational Tech Transfer for commercial product lines, ensuring close collaboration with both internal and external cross-functional teams.
  • Deliver expertise, leadership, and direction regarding GMP compliance and corporate quality governance.
  • Guide, mentor, and lead project teams dedicated to Tech Transfer.
  • Establish and maintain compliant manufacturing policies, procedures, and electronic documentation.
  • Ensure the compliant and reliable transfer of operations and procedures that meet or exceed compliance and regulatory expectations during audits, while overseeing the timely implementation of corrective actions as necessary.

Qualifications:

  • A degree (BS, MS, or PhD) in Biology, Biotechnology, Biopharmaceutical Sciences, or a related life science field, coupled with substantial industry experience in leading Tech Transfer projects within Biopharmaceutical or Cell Therapy manufacturing.
  • Proven experience in GMP manufacturing for Biologics, Vaccines, or Cell Therapy is essential.
  • Comprehensive knowledge of regulatory requirements and standards pertinent to Biologics and Pharmaceutical manufacturing is required.

Agency Note: BioTalent Ltd is acting as an employment agency in relation to this opportunity.