Cell Therapy Manufacturing Specialist

3 days ago

South San Francisco, California, United States Cellares Full time
Job Summary

We are seeking a highly motivated and innovative Cell Therapy Manufacturing Associate to join our Process Sciences team. This individual will contribute significantly to the development and manufacture of our advanced cell therapy manufacturing platform.

Key Responsibilities
  • Support manufacturing operations and day-to-day lab operations
  • Train in Process Development, Analytical Development, and/or MSAT prior to joining the Manufacturing Group
  • Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.)
  • Execute manufacturing processes in both an R&D and GMP environments, following protocols and/or standard operating procedures (SOPs)
  • 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
  • Contribute to analysis and presentation of technical results at departmental meetings
  • 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
  • Complete required training and ensure compliance with established internal and external control procedures
  • Assist in the execution of process, equipment and cleaning validation
  • Responsible for revising and originating production records, standard operating procedures, protocols and reports
  • Initiate and support the closure of Deviation Reports and CAPAs
  • Train and mentor new manufacturing associates on procedures, aseptic techniques, equipment and trouble-shooting skills
  • 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
  • Work with Quality Control, Facilities, Materials Management, Quality Assurance and Validation to complete assignments
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
  • Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries
  • Must comply with the safety policies of the company and site
  • 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
  • Excellent verbal, written, presentation, and interpersonal skills
  • Strong analytical and problem-solving skills
  • Self-motivated and passionate about advancing the field of cell therapy
  • Self-awareness, integrity, authenticity, and a growth mindset
  • Desire to be part of a rapidly evolving organization, with compelling technology, and take products and processes to the next level

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