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 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.