Massachusetts 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 Medical Affairs professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. POSITION SUMMARY The Manufacturing Training Lead is for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements. Additionally, this position is responsible for delivering cGMP, technical and organizational development training. This includes training in the areas of general and advanced knowledge of current regulations, functional job knowledge and skill development, compliance and management development in a cGMP environment. DUTIES AND RESPONSIBILITIES Essential Functions: Perform manufacturing procedures inside an ISO Class 7 cleanroom in accordance to established SOPs, cGMPs and safety regulations. Perform aseptic manipulations of cell culture processes. Document production operations in corresponding batch records and log sheets according to cGMPs and established SOPs. Deliver and administer On-The-Job (OJT) training across multiple product lines in accordance with safety guidelines, cGMPs and SOPs. Work with the Manufacturing team to evaluate personnel training needs. Coordinate new hire manufacturing training with Manufacturing Management and the Training Department as required. Coordinate cross training of existing staff with Manufacturing Management and the Training Department as required. Schedule personnel for the appropriate qualifications such as Gowning, Aseptic Technique, Personnel Qualifications (PQs). Coordinate training plans with supervisors. Able to understand manufacturing processes allowing for assistance reviewing and revising documents. Assists in deviation investigations, CAPAs, risk assessments and change controls. Other duties as assigned. Leadership Responsibilities: Understanding, observing, and adhering to the goals and policies outlined in Vericel?s Code of Business Conduct and Ethics 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. Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs. QUALIFICATIONS, EDUCATION AND EXPERIENCE Basic Qualifications: 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. Biotechnology certificate with 4+ 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. Strong experience with PowerPoint, Word and Excel. Ability to work independently under minimal supervision and direction. Preferred Qualifications: Previous experience developing and delivering training programs. Ability to assist with cross-functional project work. Organizational and planning skills and the ability to cooperate with others in a team environment will be critical to success. Learning Management System experience. Strong written and verbal communication skills. 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. Rotating holiday coverage. Ability to gown and gain entry to manufacturing areas.