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Manufacturing Associate – Cell Therapy
| Company | Adicet Bio |
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| Location | San Carlos, CA, USA |
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| Salary | $84000 – $130000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Junior, Mid Level |
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Requirements
- Bachelor’s degree in a biological science, engineering or related science discipline with 1-3 years of experience in a clinical processing and/or cell culture operations preferably in a GMP environment; or equivalent combination of education and experience.
- GMP experience in a cleanroom for cell therapy products required with previous experience in gown qualification, aseptic behavior, materials kitting, and aseptic flow of materials.
- Working knowledge and understanding of GMP, GCP, GDP, and relevant FDA guidelines.
- Process-oriented with strong analytical skills for risk identification and management.
- Excellent verbal and written communication skills and can confidently communicate with all levels of staff in this collaborative work environment.
- Self-motivated and comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Proficient in MS word, Excel, PowerPoint, Outlook and warehouse management software.
Responsibilities
- Participate in the execution of cellular drug product manufacturing according to defined SOPs and manufacturing batch records within a cleanroom environment as performer or verifier.
- Operate and troubleshoot bioprocess equipment such as Sepax, LOVO, CliniMACS, functionally closed system bioreactors, and controlled rate freezers.
- With Quality Assurance, supervisor, and Facilities, ensure preparedness for runs in terms of equipment readiness and operator training.
- Execute equipment qualifications as per approved PQ protocols.
- Perform environmental and personnel monitoring as needed.
- Troubleshoot OOE and OOT issues during routine manufacturing.
- Provide guidance and support a team of manufacturing associates.
- Collaborate with MS&T to refine MBRs and with SCM to generate supply orders to support BOM.
- Support Quality Management system including but not limited to deviation investigations and risk assessments.
- Understand and implement safety procedures.
Preferred Qualifications
- A strong background in cell therapy or CAR-T products preferred.
