Cellares

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

This listing is sourced directly from Cellares's careers page and normalized into a canonical job model.