Director, Cell Therapy Manufacturing

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).

Position Summary:

The Director, Cell Therapy Manufacturing is responsible for the leadership, oversight and strategic planning required to support the key business needs of all Cell Therapy product lines manufactured by Vericel.

Schedule:

As a company that thrives on teamwork and collaboration, this role will be required to work five days per week on-site.

Location:

This role will generally be working out of our Cambridge, MA office with an eventual move to our state-of-the-art facility located in Burlington, MA.

Position Scope:

• Responsible for oversight of assigned Cell Therapy Manufacturing operations at Vericel, to achieve delivery to our patients - right first time, on time in full.
• Drive performance and Ways of Working through Lean methodologies and processes.
• Provide leadership, guidance, and direction to staff consistent with cGMP and corporate quality governance.
• Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards, and disciplinary action.
• Oversee the training and qualification of departmental staff, ensuring proper coverage for all operations.
• Maintain and/or establish compliant manufacturing policies and procedures.
• Establish and implement key performance indicators to monitor department performance.
• Perform ongoing efficiency assessments, including staffing, capacity, and productivity.
• Seek out and implement process improvements to reduce costs and/or improve efficiencies.
• Participate as a cost center manager responsible for forecasting, headcount, project allocation and department spending.
• Interact with peers in other functional areas to ensure successful manufacturing, testing and release of final products.
• Oversee Root Cause investigations and ensure appropriate CAPAs are implemented.
• Collaborate with senior leadership in meeting corporate and site goals.

Qualifications:

• 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.
• Experience with small batch size manufacturing.
• Comfortable with MS Office suite. Experience with MES, ERP, EDMS, and Quality Events systems is preferred.
• Available for weekend, holiday and after hour coverage,
• Ability to gown and gain entry to manufacturing cleanroom areas.

Preferred Qualifications:

• Lean Six Sigma Certification or Experience.
• Experience with Lean Transformation, Change Management, and/or Industrial Culture programs.
• Root Cause Analysis, GEMBA Problem Solving or equivalent certification or experience.
• Experience with Human Error Prevention Programs (HEPP).

Why Vericel?

• Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
• Career Growth: Be a part of a growing organization with opportunities to expand your impact.
• Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.

EEO Statement
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. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.