Manufacturing of cell therapy products.
The Manufacturing Team Lead is responsible for oversight of manufacturing activities in the cleanroom for cell therapy products meeting internal and regulatory requirements.
- Provide consistent, ethical and responsible leadership to manufacturing teams to meet production demands.
- Monitor cleanroom activities to ensure compliance to all SOP and cGMP requirements.
- 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 for process consistency within the team.
- Report any inconsistencies and requests support from management or other specialists when serious problems occur. Receive guidance from supervisor.
- Maintain frequent coordination with supervisor to freely exchange ideas and to review daily cleanroom activities.
- Work closely with management to develop and maintain a cross training program within all groups in Manufacturing.
- Perform manufacturing procedures inside an ISO Class 7 cleanroom in accordance to established SOPs, cGMPs, and Safety regulations.
- Document production operations in corresponding batch records and log sheets according to cGMPs and established SOPs.
- Input data from production batch records to existing databases.
- Support deviation investigation activities.
- Communicate with the Production Planner with any changes in workload.
- Participate in the development of manufacturing policies (including operational, safety and quality programs).
- Ensure compliance with appropriate internal and regulatory policies and procedures.
- Responsible for keeping department in audit ready condition at all times.
- 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 to resolve problems prior to or when they arise.
- 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.
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 (Life Sciences or related field) or equivalent with 2+years of experience working in a cGMP environment in the biotech or pharmaceutical industry.
- Qualified in the manufacturing processes of at least one cell therapy product (e.g., Carticel, MACI, Epicel, etc.).
- Qualified as an On the Job Trainer.
- Proficient in TrackWise as an originator and investigator.
- Excellent communication skills, written and verbal.
- Must possess solid working knowledge of MS Office (Word/Excel/PowerPoint).
- Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.