Cell Therapy Manufacturing Specialist

Responsibilities

• 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