Cell Therapy Manufacturing Specialist (Swing Shift)

August 27

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Cellares

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Accelerating Access to Life-Saving Cell Therapies

biotech • biotechnology • cell therapy • manufacturing • software

51 - 200

💰 Series C on 2023-08

Description

• 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 • Other duties as assigned

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