This role will be based in our Cambridge, MA location until our new state of the art facility located in Burlington, MA is ready
Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing manufacturing professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Manufacturing Management at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.
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.
DUTIES AND RESPONSIBILITIES
Responsible for oversight of all Cell Therapy Manufacturing operations at Vericel.
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.
Provide leadership development of direct staff.
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 failure investigations and ensure appropriate CAPAs are implemented.
Collaborate with senior leadership in meeting corporate and site goals.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
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.
WORKING CONDITIONS AND PHYSICAL DEMANDS
Available for weekend, holiday and after hour coverage
Ability to gown and gain entry to manufacturing cleanroom areas.
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.