Specialist, Manufacturing
Skills
- In-depth aseptic processing and cell culture skills in a cGMP environment
- Experience operating cell therapy processing equipment (manual and automated)
- Working knowledge of validation concepts and equipment qualification
- Strong technical writing for SOPs, batch records, and GMP documentation
- Proficiency with Microsoft Word, Excel, PowerPoint and standard lab software
- Ability to manage deviations, CAPAs, and change control processes
- Root cause analysis and risk management skillset
- Ability to work independently, prioritize tasks, and support multi-shift schedules
Responsibilities
- Provide hands-on support for daily GMP manufacturing activities and multi-shift operations
- Operate automated and manual cell therapy equipment for CAR-T / CAR-M / CAR-NK processes per SOPs
- Perform in-process quality control analyses and identify/process variations
- Author and review SOPs, Master Batch Records, and other GMP documentation
- Manage deviations, change controls, and CAPAs to ensure regulatory compliance
- Support start-up, equipment qualification/validation, and continuous improvement initiatives
- Collaborate with cross-functional teams, vendors, and partners to complete assignments
- Follow aseptic processing and PPE requirements and handle leukapheresis cellular materials
- Use risk management and root cause analysis tools to investigate issues and recommend corrective actions
Education
- B.S. in Natural Sciences or Engineering required (Biology, Chemistry, Chemical/Biomedical Engineering)
- 5-7+ years of manufacturing experience in a relevant cGMP environment
- Ability to work onsite daily and flexible to support nights/weekends as needed
Benefits
- Competitive benefits package
- Health, dental, and vision coverage (typical biotech benefits)
- Paid time off and paid holidays
- Retirement savings plan (401k) and possible employer match
- Opportunities for professional development and career growth
Average salary estimate
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