Cell Therapy Manufacturing Specialist
Position Summary
Night Shift: 11:00 PM -7:30 AM
We are seeking an innovative and highly motivated Cell Therapy Manufacturing Associate 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. This is a hands-on position that will train in Process Development, Analytical Development, and/or MSAT prior to joining the Manufacturing Group.
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
This is Cellares
Cellares 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.