Forge Biologics

Technical Training Manager - GMP AAV MFG

Columbus, Ohio

Sponsorship not specifiedDetected 43 days ago

GMPMedical DevicesLeadershipMentoring

About the role

As a Technical Training Manager within the Quality Management Training team, you'll play a lead role in training and developing associates on GMP-regulated processes that support our AAV Manufacturing operations.
Reporting to the Director, GMP Quality Training, you'll own the delivery of training through hands-on and classroom instruction, actively observe performance, and mentor associates to ensure they are trained, qualified, and confident in their work.
You'll lead qualification and requalification activities, document results in compliance with GDP, and maintain your own process and gowning qualifications to serve as a subject matter expert.

Serve as a subject matter expert and technical lead for GMP Manufacturing operations, owning the delivery of training through classroom instruction, one-on-one coaching, and hands-on, on-the-job practice.
Take ownership of developing and maintaining training programs that directly support Manufacturing, working in close partnership with Manufacturing leadership and the Training team.
Lead the design of area-specific training content, on-the-job training initiatives, and qualification processes to ensure associates are fully prepared for independent work.
Own the revisions, updates, and periodic reviews of training materials, ensuring they remain current with SOPs, process changes, and continuous improvement activities.
Continuous Improvement and Support:

Coordinate and lead qualification and requalification activities by assessing proficiency, verifying proper execution of GMP-regulated processes, and ensuring all results are accurately documented in compliance with GDP.
Be cross-trained in the Training Management System (e.g., Veeva Vault) to provide oversight and ensure accuracy in recordkeeping, compliance tracking, and reporting when required.
Bachelor's degree strongly preferred. Equivalent experience may be considered.
3-5 years of experience in GMP-regulated manufacturing (biotech, pharmaceutical, or medical device), with advanced knowledge of AAV bioprocess manufacturing and aseptic techniques/practices.
Demonstrated experience leading training activities, mentoring associates, and serving as a recognized Subject Matter Expert within Manufacturing operations.
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Associate's degree in Life Sciences, Biotechnology, or a related technical field required
Bachelor's degree strongly preferred.
Equivalent experience may be considered.

This listing is sourced directly from Forge Biologics's careers page and normalized into a canonical job model.