Cellares
Manufacturing Support Services Specialist
Bridgewater, NJ
Sponsorship not specifiedDetected 114 days ago
SAPGMPCRISPRProblem Solving
About the role
- This is a hands-on position that will train in the Manufacturing and Warehouse Team.
- 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.)
- Support sample management and transport using LIMS
- Support Warehouse team with receiving of inbound consumables, labeling, and put-away using SAP and label printers
- Supports the maintenance and supply of warehouse storage
- Perform routine clean room and laboratory activities, including ordering of consumables and PPE items, 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
- Train and mentor new manufacturing support services associates on procedures, aseptic techniques, equipment, and troubleshooting skills
- Review in-process and completed documents for accuracy and to make sure batch records are turned in to area management within the specified days of completion
- Provide user feedback to engineering and process teams, support with requirements gathering and review
Requirements
- 1-2 years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy
- Ability to lift 30 pounds
- 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
Nice to have
- Bachelor's Degree or a diploma in a scientific or related field is preferred
- SAP and LIMS experience is preferred
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This listing is sourced directly from Cellares's careers page and normalized into a canonical job model.