Training Lead, Cell Therapy Manufacturing
Training Lead, Cell Therapy Manufacturing
Manufacturing of cell therapy products.
The Manufacturing Training Lead is responsible for delivering cGMP, technical training. This includes training in the areas of general and advanced knowledge of current regulations, functional job knowledge and skill development, compliance in a cGMP environment. Responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.
- 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.
- Input data from production records to existing databases.
- Develop and maintain a method to ensure that compliance to training is achieved by staff.
- 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 and participate in the development and delivery of training materials.
- Schedule personnel for the appropriate qualifications such as Gowning, Aseptic Technique, Personnel Qualifications (PQs).
- Deliver New Hire training and identify needs / solutions for on-going training.
- Collect and provide data for monthly department training metrics.
- Participate on training projects with cross functional team members.
- Plan and drive cross training of the manufacturing groups with measurable time lines.
- Assist with delivery/training setup for Subject Matter Experts (SMEs) delivering training (WebEx, presentations, etc.).
- Manage requests and ongoing updates for learning plan requests.
- Manage course evaluations and other training effectiveness tools (instructor feedback, in class evaluations, exams, etc.).
- Participate in determining objectives of significant projects or assignments,
- Able to understand the manufacturing processes in order to assists in reviewing and revising documents.
- Assists in deviation investigations, CAPAs, risk assessments and change controls.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
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.
- Bachelor’s degree (Life Sciences or related field) or equivalent with 2+ years of experience in Manufacturing and/or Quality positions.
- 2+ years of experience working in cGMP
- Strong experience with PowerPoint, Word, Excel, and database management and reporting.
- Ability to work independently under minimal supervision and direction.
- Ability to take on a leadership role within multiple teams.
- Strong written and verbal communication skills.
- 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.
WORKING CONDITIONS AND PHYSICAL DEMANDS
- Flexibility in work schedule.
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.