Training Specialist

Vericel Corporation • Burlington, MA

5h • $27 - $34 • Onsite

About The Position

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).

Position Summary:

The Manufacturing Training Specialist trains technicians to execute the specific process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements. Additionally, this position is responsible for delivering cGMP, technical training which 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.

Schedule: This role will be required to work on-site Monday - Friday with the ability to periodically work one weekend day to meet the training demand as necessary. This role is based in our new Burlington facility.

Requirements

• Bachelor's degree with at least 2 years of experience working in a cGMP environment in the biotech or pharmaceutical industry or Biotechnology certificate with 4+ years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry
• Mastery of Vericel’s Manufacturing procedures – Minimum of 2 years of successful Vericel Manufacturing Process Experience
• Demonstrated success as a Qualified Trainer for at least three (3) aseptic processing operations.
• Proven ability to provide feedback in a coaching manner while maintaining the integrity of the SOP and regulatory requirements.
• Strong experience with PowerPoint, Word and Excel.
• Organizational and planning skills and the ability to cooperate with others in a team environment will be critical to success.
• 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.

Nice To Haves

• Previous experience developing and delivering training programs.
• Ability to assist with cross-functional project work.
• Learning Management System experience.
• Strong written and verbal communication skills.

Responsibilities

• Deliver and administer On-The-Job (OJT) training across multiple product lines in accordance with safety guidelines, cGMPs and SOPs.
• Demonstrate to new staff how to perform manufacturing procedures inside an ISO Class 7 cleanroom in accordance with established SOPs, cGMPs and safety regulations.
• Demonstrate aseptic manipulations of cell culture processes.
• Document production operations in corresponding batch records and log sheets according to cGMPs and established 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 to ensure assignment and completion in LMS.
• Coordinate cross training of existing staff with Manufacturing Management.
• Coordinate training plans with supervisors and schedulers.
• Schedule personnel for the appropriate qualifications such as Gowning, Aseptic Technique, Personnel Qualifications (PQs).
• Assist in reviewing and revising documents as a result of deep understanding of manufacturing processes.
• Assists in deviation investigations, CAPAs, risk assessments and change controls.
• Other duties as assigned.

Benefits

• Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
• Career Growth: Be a part of a growing organization with opportunities to expand your impact.
• Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level