Director, MACI Manufacturing
Director, MACI Manufacturing
The Director, MACI Manufacturing is responsible for the leadership, oversight and strategic planning required to support the key business needs of the MACI product line.
- Oversight of MACI Cell Therapy Manufacturing.
- Provide leadership, guidance, and direction to staff consistent with CGMP and company 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 MACI specific training and qualification program and trainers
- Maintain and as necessary establish compliant manufacturing policies, procedures, and validation.
- Track and trend department performance; establish and implement key performance indicators (KPIs).
- Perform ongoing efficiency assessments and improvements, including staffing, capacity, and productivity.
- 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.
- Ensure process improvements and goals are delivered on schedule and within budget.
- Collaborate with senior leadership in meeting corporate and site goals.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
- Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
- Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
- 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.
WORKING CONDITIONS AND PHYSICAL DEMANDS
- Available for weekend, holiday and after hour coverage.
- Ability to gown and gain entry to manufacturing areas.
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.