Director of Technical Transfer

4 days ago

Burlington, Massachusetts, United States Vericel Corporation Full time
Job Opportunity

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, is seeking a highly skilled professional to fill the role of Director of Technical Transfer. This position will be based full time in our new, state-of-the-art facility located in Burlington, MA.

Job Summary

The Director of Technical Transfer will be responsible for enhancing the efficiency of the company's technical transfer process and improving overall operational performance. This role involves providing leadership, overseeing operations, strategic planning, and fostering close collaboration with a cross-functional team.

Key Responsibilities

  • Lead the technical transfer process for commercial product lines, partnering closely with internal and external cross-functional teams.
  • Provide guidance and participation to ensure compliance with cGMP and company corporate quality governance.
  • Coach and mentor a project team focused on operational transfer.
  • Maintain and/or establish compliant manufacturing policies, procedures, and electronic records.
  • Ensure the reliable transfer of operations and procedures that meet or exceed compliance and regulatory expectations in audits.
  • Perform ongoing efficiency assessments and improvements, including staffing, capacity, and productivity.
  • Collaborate with peers in cross-functional areas to ensure successful and timely project execution.

Requirements

  • Bachelor's or master's degree in biotechnology, biology, biomedical engineering, or equivalent.
  • 10+ years of experience in biologic, cell therapy, or vaccine manufacturing.
  • 6+ years of management experience in an aseptic processing or similar environment.
  • Strong understanding of cell biology and cell culture.
  • Knowledgeable on regulatory requirements and standards affecting Biologics, Medical Devices, and Pharmaceuticals.
  • Experience with small-scale batch size manufacturing.
  • Comfortable with MS Office suite.
  • Lean Manufacturing Experience preferred.
  • Experience in cGMP production environments.

Working Conditions and Physical Demands

  • Available for weekend, holiday, and after-hour coverage.
  • Ability to gown and gain entry to manufacturing areas.

EEO Statement

Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability.

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