Manufacturing of cell therapy products.
The Supervisor, Manufacturing is responsible for oversight of manufacturing activities for cell therapy products meeting internal and regulatory requirements.
- Master all Team Lead, Manufacturing core responsibilities.
- Assist in selection, development, and motivation of qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
- Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
- Coach and mentor staff in all aspect of their job performance and career development including training, feedback, rewards and disciplinary action.
- Work with team and training leads to develop work plans, assign tasks, and supervise team(s).
- Supervise staff in the Manufacturing environment.
- Generate the daily manufacturing schedule and master day sheet.
- Actively perform and oversee daily cell culture activities to assure compliance with all company and regulatory procedures.
- Conduct annual performance reviews and provide regular feedback based on goals.
- Organize the staff and workload to meet or exceed productivity performance standards.
- Complete corrective action plans to address deficient areas identified and to ensure adherence to compliance.
- Be available on-call.
- Serve as manufacturing SME for audit activities (internal & external)
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 degree or equivalent and 4+ years of working in GMP environment in the biotech or pharma industry
- Must possess solid working knowledge of MS Office.
- Fully trained with manufacturing of one cell therapy product.
- Previous supervisory experience.
- Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.
- Excellent communication skills, written and verbal.
WORKING CONDITIONS AND PHYSICAL DEMANDS
- May be required to sit for long periods of time while performing cell culture operations.
- Must be able to lift, carry, push and pull up to 50 lbs.
- Schedule is Sunday - Thursday, 1st shift
- Rotating holiday 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.