Cell Therapy Specialist I - FT - Santa Ana

Job Summary

The Cell Therapy Specialist I is part of the NK cell therapy manufacturing team. The position will be expected to support the successful tech transfer and operational readiness process. The CTS I will use 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 I 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.

General Accountabilities

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
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

Education: Bachelors in relevant science or engineering discipline
1-3 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