Cell Processing Specialist I, PM (Weekends)

Role Summary

On-site in Morris Plains, NJ. The Cell Processing Specialist I is responsible for cell washing operations and verification of intermediate processing days for patient-derived clinical and commercial cellular immunotherapy products. They will formulate and verify all media lots, and due to the starting material (patient cells) require a high level of proficiency and ownership of the process and media formulation. Shift: Weekend Nights (Fri–Mon), PM Shift, 1–11:30pm.

Responsibilities

• Ability to aseptically gown and work in ISO 8, 7, and 5 cleanroom environments and stand for extended periods. Skilled in cell washing with automated equipment.
• Verification of intermediate process days which include expertise with the wave bioreactor, NC-200 and in-process environmental monitoring.
• Maintains and prepares equipment/environment for use. Proficient in the use of production related IT systems such as SAP, LIMS and MES. Documents all steps in the assigned batch record in line with GMP requirements.
• Executes processing/verification of media lots with top-level aseptic technique and performs routine and dynamic environmental monitoring.
• Assists in Deviation Investigations, Inspections, and participates in qualification/validation activities.
• Responsible for successful on-time completion of required training curriculum comprising of the necessary Global Operating Procedures (GOPs), Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role.
• Requires handling of chemicals such as corrosives, solvents & bio-hazardous materials.

Qualifications

• Required: HS diploma or GED; a minimum of 1 year experience in cGMP, academic, or lab setting with aseptic experience. An Associate’s degree or Bachelor’s degree in relevant Engineering or Scientific discipline may be considered in lieu of industry experience.
• Required: Ability to perform complex calculations and an understanding of scientific notations.
• Required: Ability to work with magnetic field equipment.
• Required: Ability to lift 50 lbs., assisted.
• Required: Near vision performance equivalent to 20/20 with no impairment of color vision; corrective lenses permitted.
• Required: Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Required: Knowledge of universal precautions for handling human derived materials in BSL-2 containment areas.
• Preferred: Experience in cell therapy manufacturing.
• Preferred: Experience with aseptic processing in ISO 5 biosafety cabinet.