Cell Therapy Manufacturing Specialist

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 reviewSupport reagent preparation, leukopak processing, and sample testing in an R&D and GMP environmentContribute to analysis and presentation of technical results at departmental meetingsPerform routine clean room and laboratory activities including ordering, cleaning, restocking, and equipment qualification/maintenanceOperate in a controlled GMP environment and perform gowning as per procedureComplete required training and ensure compliance with established internal and external control proceduresAssist in the execution of process, equipment and cleaning validationResponsible for revising and originating production records, standard operating procedures, protocols and reportsInitiate and support the closure of Deviation Reports and CAPAsTrain and mentor new manufacturing associates on procedures, aseptic techniques, equipment and trouble-shooting skillsReview in-process and completed documents for accuracy and to make sure batch records are turned in to area management within specified days of completionWork with Quality Control, Facilities, Materials Management, Quality Assurance and Validation to complete assignmentsOther duties as assigned Requirements Bachelor’s Degree or diploma in a scientific or related field is required1+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapyMust 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 injuriesMust comply with the safety policies of the company and siteAdherence to cGMPs is required at all times during the manufacturing of Cell Therapy productsProficiency in Drug Product-related process equipmentMust have experience following protocols, SOPs, and/or GMP documentationExcellent verbal, written, presentation, and interpersonal skillsStrong analytical and problem-solving skillsSelf-motivated and passionate about advancing the field of cell therapySelf-awareness, integrity, authenticity, and a growth mindsetDesire to be part of a rapidly evolving organization, with compelling technology, and take products and processes to the next level 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. Additional Information This is CellaresCellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.

Apply Now