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Team Lead, Cell Therapy Manufacturing
2 months ago
POSITION SUMMARY
The Manufacturing Team Lead is responsible for leadership and oversight of Cell Therapy Manufacturing activities at Vericel, ensuring all scheduled daily operations are completed on time and in accordance with all applicable Quality and Regulatory requirements.
DUTIES AND RESPONSIBILITIES
Essential Functions:
- Provide consistent, ethical and responsible leadership to manufacturing teams to meet production demands.
- Lead junior manufacturing operators, ensuring that all scheduled daily operations are completed on time and in compliance with approved procedures.
- Monitor cleanroom activities to ensure compliance to all Vericel SOP and cGMP requirements.
- Ensure the manufacturing operation is maintained in an audit-ready condition at all times.
- Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
- Serve as a communications liaison between employees and management staff/support groups.
- Work with management to develop work plans, assign tasks, and coach and mentor team(s).
- Ensure staff has appropriate knowledge of department processes and procedures.
- Observe activities performed by junior team members and provide corrective feedback as necessary.
- Report any inconsistencies to management when problems occur. Receive guidance from management regarding remediation.
- Maintain frequent coordination with Manufacturing Management to freely exchange ideas and to review daily cleanroom activities.
- Work closely with management to implement and maintain the cross-training program within all Manufacturing teams.
- Perform manufacturing procedures inside an ISO Class 7 cleanroom in accordance to established SOPs, cGMPs, and Safety regulations.
- Perform aseptic cell culture manipulations as required to produce cell therapy products.
- Document all production operations in electronic batch records and/or paper log sheets according to cGMPs and established SOPs.
- Input data from production batch records to existing databases.
- Assist in deviation investigations, CAPA’s, risk assessments and change controls.
Additional Responsibilities:
- Directly supervise staff under guidance of senior management (e.g., Manufacturing Supervisor, Manager, etc.) including task assignment and work plans.
- Reconcile and approve time detail for direct reports in the time system and partner with manager to keep OT expenditures within budget.
- Assist with coaching and mentoring of staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action.
- Participate in the development of manufacturing policies (including operational, safety and quality programs).
- Monitor the staff and workload to meet or exceed productivity performance standards.
- Work with management to complete corrective action plans to address deficient areas identified and to ensure adherence to compliance.
- Recommend and develop ideas for improvement in operating methods and procedures.
- Required to be present in the Clean Room for the majority of daily operations, covering early morning and/or closing duties at the end of the day, including lab monitoring responsibilities.
- Perform culture checks to ensure quality and compliance to procedures.
- Serve as a technical resource for questions and / or investigate manufacturing issues.
- Assist Management in conducting annual performance reviews and provide regular feedback based on goals.
- Other duties as assigned.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
Basic Qualifications:
- Bachelor’s Degree (Life Sciences or related field) or equivalent with 2 - 4+ years of experience working in a cGMP environment in the biotech or pharmaceutical industry.
- Biotechnology certificate with 4 – 6+ years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry or GED or equivalent plus 8-10+ years of cGMP experience.
- Demonstrated ability to lead a team of workers in a high-pressure and highly regulated production environment.
- Hands-on experience performing aseptic operations in a cGMP environment.
- Capable of being qualified as an On the Job Trainer.
- Proficient in Quality Events management software systems such as TrackWise or equivalent.
- Must possess solid working knowledge of MS Office (Word/Excel/PowerPoint).
Preferred Qualifications:
- 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.
- Ability to work 1 weekend day per week.
- Rotating holiday coverage.
- Ability to gown and gain entry to manufacturing 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.
