Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing operational 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 Operations and Engineering 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 of Technical Transfer is a key figure in enhancing the efficiency of the company's technical transfer process and improving overall operational performance. The role involves providing leadership, overseeing operations, strategic planning, and fostering close collaboration with a cross-functional team. The Director holds a key leadership role in the transfer of commercial cell therapy products.
DUTIES AND RESPONSIBILITIES
Essential Functions:
- Spearhead operational technical transfer related to commercial product lines partnering closely with internal and external cross functional teams.
- Provide leadership, guidance, and participation to comply 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.
- Compliantly and reliably transfer operations and procedures that will meet or exceed compliance and regulatory expectations in audits. Oversee and ensure on-time implementation of corrective actions as applicable.
- 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.
- Ensure process improvements are incorporated into the transfer of operations.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
- 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.
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