Manufacturing Training Lead

Manufacturing Training Lead

POSITION SUMMARY

Department Description:

Manufacturing of cell therapy products.

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.

ESSENTIAL FUNCTIONS

Core Responsibilities:

  • 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.
  • 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.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:

An ongoing commitment to conducting our 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.

Basic Qualifications:

  • Bachelor’s degree (Life Sciences or related field) or equivalent with 2+ years of experience in Manufacturing and/or Quality positions, or Biotechnology certificate or equivalent and 4+ years experience.
  • 2+ years of experience working in cGMP
  • 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.

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

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

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