Massachusetts Veterans Jobs

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing manufacturing professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. 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 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: Please see Vericel.com job posting for other responsibilities 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.