Cell Processing Specialist I (Tues-Sat)
Novartis
- Morris Plains, NJ
- Permanent
- Full-time
365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives.The Cell Processing Specialist I is responsible for cell washing operations and verifying cell processing intermediate processing days of patient derived clinical and commercial cellular immunotherapy products. Cell Processing Specialist I will also be responsible for the formulation and verification of all media lots. Due to the nature of the starting material (patient cells) this role requires high level of proficiency and ownership of the process and media formulation.Key Responsibilities:
- Ownership for the processing of the assigned Patient starting material in the clean room environment.
- Ability to gown aseptically and work in a clean room environment (ISO 8, 7 and ISO 5) areas for extended periods of time. Cell washing with the ability to work with automated equipment such as the CS5.
- 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.
- Conduct all necessary processing/verification steps for the assigned lot with highest skill level of aseptic technique. Conducts routine and dynamic environmental monitoring as required.
- 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.
- Assist on Deviation Investigations and Inspections. Participation in assigned qualification/ validation activities. Perform other duties as assigned, ie. batch record review, process streamline improvements, safety walk-throughs.
- Ability to work different shift, weekends and overtime will be required. Your shift will be fixed according to business need.
- Ability to work with magnetic field equipment.
- Ability to lift 50 lbs unassisted.
- Ability to stand for an extended period of time
- Requires handling of chemicals such as corrosives, solvents & bio-hazardous materials.
- HS diploma or GED required. A minimum of 1 year experience in cGMP, academic or lab setting with aseptic experience. Associate's degree or bachelor's degree in relevant Engineering or Scientific discipline may be considered in lieu of industry experience.
- Ability to perform complex calculations and an understanding of scientific notations required.
- Experience in cell therapy manufacturing preferred.
- Experience desired in: 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 manufacturing.