Cell Therapy Manufacturing Specialist

Position Summary Night Shift: 6 PM-6 AM We are seeking an innovative and highly motivated Cell Therapy Manufacturing Specialist to join our Process Sciences team who will contribute significantly to the development and manufacture of our advanced cell therapy manufacturing platform. The primary focus of this position will be to support manufacturing operations, as well as day-to-day lab operations. 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.) 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 Compensation $20 - $45 an hour Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, and Onsite lunches. All displayed pay ranges are approximate, negotiable, and location dependent. #J-18808-Ljbffr