Vertex Pharmaceuticals seeks a Manufacturing Operations Supervisor for second-shift cell manufacturing leadership in Boston. The role involves managing a team of up to 8 personnel performing GMP cell processing operations, with responsibility for regulatory compliance, personnel development, and technical expertise in clinical cellular product manufacturing.
Responsibilities
- Build and develop team of 2-8 direct reports; hire, orient, train, and coach personnel
- Ensure cGMP compliance through oversight, education, and investigation of quality events
- Manage personnel scheduling in coordination with manufacturing leadership
- Create, revise, and review SOPs and batch records for manufacturing operations
- Troubleshoot technical problems independently and serve as subject matter expert
Requirements
- Extensive GMP experience with documented lead or trainer background
- Minimum 3 years cell culture experience in adherent and suspension cultures
- 0-2 years direct supervisory or team leadership experience
- Working knowledge of 21 CFR 210, 211, and 820 regulatory requirements
- Expertise in cell processing and bioreactor technologies for clinical manufacturing
- Proficiency with Word, Excel, Project, Outlook, and electronic quality systems
Supervisor, Manufacturing Operations (Second Shift) in boston at Unknown Company
This position is listed as full time and onsite.