The Cell Therapy Specialist III is a manufacturing subject matter expert (SME) for the NK cell therapy manufacturing process. The position will be expected to support the successful tech transfer and operational readiness process. The CTS III will use expert knowledge of cGMP regulations and project management to ensure manufacturing readiness. Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of cell therapy products and promote a culture of quality and compliance. Ensure all processes and procedures related to operations are in full compliance with cGMP, CFR and site quality systems and company policies. Upon start of clinical manufacturing the CTS III will be part of a cohesive team responsible for Deviations, CAPAs, Change Controls and is expected to be able to work independently with minimal supervision.
- Performing patient process unit operations and support operations described in standard operating procedures and batch records
- Accurate and timely completion of documentation required by protocols, standard operating procedures, and batch records.
- Performing tasks in a manner consistent with safety policies, quality systems, and GMP requirements.
- Timely completion of training assignments to ensure the necessary technical skills and knowledge
- Assisting in setting up manufacturing areas and equipment.
- Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
- Work with management to establish and maintain daily unit operations schedule that includes people, product, and material flow across multiple shifts
- Routine monitoring of equipment
- Maintain aseptic technique during processing of products to ensure the integrity, viability and sterility of cellular products until release
- Must follow special cleaning and gowning procedures for the facility. Required to work in cleanroom environment requiring specialized gowning such as double gloves, hair net, masks, safety glasses, sterile jumpsuit and shoe covers
- Perform error free calculations of cell concentrations, dilutions, viabilities during production
- Must maintain and apply knowledge regarding patient information, screening and testing, labeling and product acceptability and release criteria
- Be flexible and adaptable to schedule and procedural changes to ensure timely preparation of products with highest quality
- Maintains current inventory of supplies
- Other duties as assigned
Job Qualifications and Skills
- Education: Bachelors in relevant science or engineering discipline
- 5+ years of experience in a cGMP biologics or cell therapy manufacturing
- Preferred record of leading and training manufacturing staff
- Cell culture processing experience in handling and propagation of human primary cell
- Aseptic processing in ISO 5 biosafety cabinets
- Universal precautions for handling human derived materials in BSL-2 containment areas
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy
- Excellent interpersonal, oral and written communication skills. Strong technical writing ability required
- Ability to work off-shift and long hours as required
- Ability to lift over 30lbs