Senior Manager, Process Optimization
2 weeks ago
Vericel Corporation, a frontrunner in innovative therapies for sports medicine and critical burn care, presents a remarkable opportunity for a distinguished operational leader eager to contribute to a thriving commercial entity with a well-established array of advanced cell therapies and specialty biologics. This role reports directly to the Operations and Engineering Management team at Vericel, offering a chance to be part of a rapidly growing organization supported by a robust financial foundation and a dedicated team committed to enhancing patient outcomes.
ROLE SUMMARY
The Senior Manager of Process Optimization plays a pivotal role in refining the efficiency of the technical transfer process within the organization, thereby enhancing overall operational effectiveness. This position encompasses leadership responsibilities, operational oversight, strategic planning, and fostering collaboration across various functional teams. The Senior Manager is instrumental in the transition of commercial cell therapy products.
KEY RESPONSIBILITIES
Essential Duties:
- Lead the operational technical transfer initiatives related to commercial product lines, collaborating closely with both internal and external cross-functional teams.
- Provide strategic leadership and guidance to ensure compliance with current Good Manufacturing Practices (cGMP) and corporate quality standards.
- Mentor and coach project teams focused on operational transfers.
- Establish and maintain compliant manufacturing policies, procedures, and electronic documentation.
- Ensure the reliable transfer of operations and procedures that meet or exceed compliance and regulatory standards during audits, overseeing timely implementation of corrective actions as necessary.
- Conduct ongoing assessments to identify efficiency improvements in staffing, capacity, and productivity.
- Work collaboratively with peers across functional areas to guarantee successful and timely execution of projects.
- Incorporate process enhancements into the operational transfer framework.
LEADERSHIP EXPECTATIONS
- Understand, adhere to, and promote the goals and policies outlined in Vericel's Code of Business Conduct and Ethics.
- Demonstrate honesty and treat colleagues with respect and courtesy.
- Continuously strive to enhance Vericel as a desirable workplace and a company recognized for the quality of its personnel and products.
- Act as a role model for fellow employees and business partners by conducting oneself responsibly, fairly, and honestly, while exercising sound judgment in all professional interactions.
QUALIFICATIONS AND EXPERIENCE
- Bachelor's or master's degree in biotechnology, biology, biomedical engineering, or a related field.
- Over 10 years of experience in biologics, cell therapy, or vaccine production.
- At least 6 years of management experience in an aseptic processing or comparable environment.
- Strong knowledge of cell biology and cell culture techniques.
- Familiarity with regulatory requirements and standards applicable to Biologics, Medical Devices, and Pharmaceuticals.
- Experience in small-scale batch manufacturing processes.
- Proficient in the Microsoft Office suite.
- Lean Manufacturing experience is preferred.
- Experience in cGMP production settings.
WORKING ENVIRONMENT AND REQUIREMENTS
- Availability for weekend, holiday, and after-hours support as needed.
- Ability to gown and gain access to manufacturing areas.
EEO STATEMENT
All applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.
Vericel Corporation is a VEVRAA federal contractor and seeks priority referrals of protected veterans for job openings at all locations.
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