Manufacturing Training Supervisor

2 weeks ago

Cambridge, Massachusetts, United States Vericel Corporation Full time
Job Overview

Vericel Corporation, a frontrunner in innovative therapies for sports medicine and severe burn care, presents an exceptional opportunity for a skilled manufacturing expert eager to contribute to a well-established commercial organization with a distinctive range of advanced cell therapies and specialty biologics. This role reports directly to the Manufacturing Management team at Vericel, offering a chance to be part of a rapidly growing company with a robust financial foundation and a dedicated group of professionals focused on enhancing patient outcomes.

POSITION SUMMARY

The Manufacturing Training Lead is responsible for executing the process steps necessary for the production of commercial cell therapy products that comply with both internal and regulatory standards. This role also encompasses the delivery of cGMP, technical, and organizational development training, covering essential areas such as regulatory knowledge, functional job skills, compliance, and management development within a cGMP framework.

KEY RESPONSIBILITIES

Core Functions:

  • Conduct manufacturing operations within an ISO Class 7 cleanroom, adhering to established SOPs, cGMPs, and safety protocols.
  • Perform aseptic techniques related to cell culture processes.
  • Accurately document production activities in relevant batch records and log sheets, following cGMPs and established SOPs.
  • Facilitate and provide On-The-Job (OJT) training across various product lines, ensuring compliance with safety standards, cGMPs, and SOPs.
  • Collaborate with the Manufacturing team to assess personnel training requirements.
  • Coordinate training for new hires in conjunction with Manufacturing Management and the Training Department as necessary.
  • Oversee cross-training initiatives for existing staff alongside Manufacturing Management and the Training Department as needed.
  • Organize scheduling for necessary qualifications such as Gowning, Aseptic Technique, and Personnel Qualifications (PQs).
  • Align training plans with supervisory staff.
  • Possess a comprehensive understanding of manufacturing processes to assist in reviewing and updating documentation.
  • Support deviation investigations, CAPAs, risk assessments, and change controls.
  • Perform additional duties as assigned.

LEADERSHIP RESPONSIBILITIES:

  • Uphold and adhere to the goals and policies outlined in Vericel's Code of Business Conduct and Ethics.
  • Demonstrate honesty and treat all individuals with respect and courtesy.
  • Aim to enhance Vericel's workplace culture and foster a company recognized for the caliber of its personnel and products.
  • Act as a role model for colleagues and business partners by engaging responsibly, fairly, and honestly in all interactions, exercising sound judgment in job performance.

QUALIFICATIONS, EDUCATION, AND EXPERIENCE

Basic Qualifications:

  • Bachelor's Degree in Life Sciences or a related field, or equivalent experience, with a minimum of 2 years in a cGMP environment within the biotech or pharmaceutical sectors.
  • Biotechnology certification with at least 4 years of experience in a cGMP setting in the biotechnology or pharmaceutical industry, or a GED/equivalent with 8-10+ years of cGMP experience.
  • Proficient in PowerPoint, Word, and Excel.
  • Ability to work independently with minimal supervision.

Preferred Qualifications:

  • Prior experience in developing and delivering training programs.
  • Capability to assist with cross-functional project initiatives.
  • Strong organizational and planning skills, with a collaborative approach in a team environment.
  • Experience with Learning Management Systems.
  • Excellent written and verbal communication abilities.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • May require prolonged periods of sitting while conducting cell culture operations.
  • Must be capable of lifting, carrying, pushing, and pulling up to 50 lbs.
  • Availability to work one weekend day.
  • Participation in rotating holiday coverage.
  • Ability to gown and gain access to manufacturing areas.

EEO Statement

All applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.

Vericel Corporation is a VEVRAA federal contractor and seeks priority referrals of protected veterans for job openings at all locations.

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