Cellares
Cell Therapy Manufacturing Specialist
South San Francisco, CA
Sponsorship not specifiedDetected 1168 days ago
GMPCRISPRProblem Solving
About the role
- This is a hands-on position that will train in Process Development, Analytical Development, and/or MSAT prior to joining the Manufacturing Group.
- Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.
Responsibilities
- Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.)
- Provide user feedback to engineering and process teams, support with requirements gathering and review
- Support reagent preparation, leukopak processing, and sample testing in an R&D and GMP environment
- Perform routine clean room and laboratory activities including ordering, cleaning, restocking, and equipment qualification/maintenance
- Operate in a controlled GMP environment and perform gowning as per procedure
- Initiate and support the closure of Deviation Reports and CAPAs
- Review in-process and completed documents for accuracy and to make sure batch records are turned in to area management within specified days of completion
Requirements
- Bachelor's Degree or diploma in a scientific or related field is required
- 1+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy
- Adherence to cGMPs is required at all times during the manufacturing of Cell Therapy products
- Proficiency in Drug Product-related process equipment
- Must have experience following protocols, SOPs, and/or GMP documentation
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