Team Lead, Cell Therapy Manufacturing

Role 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. Schedule: in-office Wednesday-Saturday.

Responsibilities

• Provide consistent, ethical and responsible leadership to manufacturing teams to meet production demands consistent with cGMP and company corporate quality governance.
• Ensure staff receive effective training and qualification on department processes and procedures.
• Accountable for team performance of manufacturing procedures inside an ISO Class 7 cleanroom in accordance with established SOPs, cGMPs, and safety regulations.
• Monitor cleanroom activities to ensure compliance to all Vericel SOP and cGMP requirements and all areas and operations are always maintained in an audit-ready condition.
• Lead and coach manufacturing technicians, ensuring that all scheduled daily operations are completed on time and in compliance with approved procedure while meeting or exceeding productivity performance standards.
• Develop work plans, assign tasks, and coach and mentor team(s).
• Conduct annual performance reviews and provide regular feedback based on goals.
• Perform culture checks to drive engagement and retention within our teams.
• Routinely observe activities performed by team members and provide constructive feedback to support technician development and operational success.
• Report any inconsistencies or events to management when problems occur. Receive and implement guidance from management regarding remediation.
• Partner with management to freely exchange ideas, recommend and develop ideas for improvement in operating methods and procedures and to review daily cleanroom activities as well as participate in the development of manufacturing policies (including operational, safety and quality).
• Work closely with management to implement and maintain the cross-training program within all Manufacturing teams.
• Reconcile and approve time detail for direct reports in the time system and partner with manager to keep OT expenditures within budget.
• Input data from production batch records to existing databases.
• Assist in deviation investigations, CAPA's, risk assessments and change controls.
• Be present in the Clean Room for the majority of daily operations, carrying assigned day-sheet, and ensure coverage of early morning and/or closing duties at the end of the day, including lab monitoring responsibilities.
• Serve as a technical resource for questions, and/or investigate manufacturing issues.
• Daily performance of aseptic cell culture manipulations as required to produce cell therapy products with own day-sheet activities to maintain mastery.
• Document all production operations in electronic batch records and/or paper log sheets according to cGMPs and established SOPs.
• Other duties as assigned.

Qualifications

• Required: 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.
• Required: 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.
• Required: Demonstrated proficiency with aseptic operations—recognized among peers and management for their process competence and training skills (QT).
• Required: Demonstrated ability to lead a team of workers to build and sustain a positive, supportive, team-focused environment.
• Required: Hands-on experience performing aseptic operations in a cGMP environment.
• Required: Qualified as an On the Job Trainer in at least one aseptic process.
• Required: Proficient in Quality Events management software systems such as TrackWise or equivalent.
• Required: Must possess solid working knowledge of MS Office (Word/Excel/PowerPoint).
• Preferred: Recognized by peers and leaders for their mastery of aseptic processing and continuous improvement mindset and implementation.
• Preferred: Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.
• Preferred: Excellent communication skills, written and verbal.