Sr. Manufacturing Associate, cGMP Manufacturing
Core
Execute critical cGMP manufacturing operations for regenerative medicine products in a controlled cleanroom environment, including aseptic processing, material preparation, and equipment operation.
Role type
Senior individual contributor manufacturing associate (cGMP)
Builds
Clinical and commercial regenerative medicine products
Domain
Pharmaceutical manufacturing (cell & gene therapies)
Required skills
cGMP manufacturing principles, aseptic processing, cleanroom operations, GMP documentation, deviation management, CAPA, change control, process validation, troubleshooting, equipment operation, gowning procedures
Preferred skills
Facility start-up experience, process validation support, cell/tissue culture background, BSC/isolator experience, ISO 7/8 cleanroom operations, Lean/5S/Kaizen
Technologies
BSCs, isolators, cleanroom equipment
Responsibilities
Execute aseptic processing and material preparation in cleanroom; Author, review, and manage SOPs and batch records; Support process validation and facility start-up; Troubleshoot manufacturing processes and perform root cause analysis; Participate in continuous improvement initiatives (5S, Kaizen); Train and coach junior associates
Seniority
Senior, hands-on IC