Manufacturing Director

1 day ago


Cambridge, Massachusetts, United States Vericel Corporation Full time
Job Summary

We are seeking a highly experienced and skilled Manufacturing Director to lead our Cell Therapy Manufacturing operations at Vericel Corporation. As a key member of our team, you will be responsible for overseeing all aspects of manufacturing, ensuring compliance with cGMP regulations, and driving process improvements to enhance efficiency and productivity.

Key Responsibilities
  • Lead and manage a team of manufacturing professionals to ensure seamless operations and high-quality products.
  • Develop and implement manufacturing policies and procedures to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to identify and implement process improvements, reducing costs and enhancing efficiency.
  • Provide coaching and mentoring to staff to enhance their skills and career development.
  • Oversee training and qualification of departmental staff to ensure proper coverage for all operations.
  • Establish and implement key performance indicators to monitor department performance and drive continuous improvement.
Requirements
  • Bachelor's degree in biotechnology, biology, biomedical engineering, or equivalent.
  • 10+ years of experience in cGMP biologics, cell therapy, or vaccine manufacturing.
  • 6+ years of management experience in a cGMP aseptic processing or similar environment.
  • Strong understanding of cGMPs, cell biology, and cell culture.
  • Knowledgeable on regulatory requirements and standards affecting Biologics, Medical Devices, and Pharmaceuticals.
Working Conditions and Physical Demands
  • Available for weekend, holiday, and after-hour coverage.
  • Ability to gown and gain entry to manufacturing cleanroom areas.

Vericel Corporation is an Equal Opportunity/Affirmative Action Employer and a VEVRAA federal contractor. We are committed to diversity and inclusion in the workplace and welcome applications from qualified candidates of all backgrounds.


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