US-NJ, Cell Processing Specialist CAR-T Cell Therapy 218987BR_1504102696-MZ
|Our vision is to support people with cancer through innovation and community. |
We're very proud to be expanding new frontiers in cancer treatment by advancing immunocellular therapy for children and young adults with r/r B-cell ALL and other critically ill patients who have limited options.
Come to an industry leader where you will be responsible for end to end processing/verification of patient derived clinical and commercial cellular immunotherapy products.
Due to the nature of the starting material (patient cells) this role requires the highest level of proficiency and ownership.
•End to End 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.
•Maintains and prepares equipment/environment for use.
•Ability to work with automated cell processing equipment such as Elutra, CS5, Sepax.
•Knowledgeable in the use of production related IT systems such as SAP 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.
•sound cell biological decision making.
•Assist on Deviation Investigations, Change Controls, Safety Inspections and CAPAs.
•execution of assigned qualification/ validation activities.
•Responsible for Successful on time completion of required training curriculum comprising 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.
•Perform other duties as assigned for example: Successful completion of assigned PU project initiatives and/or work stream tasks, such as process improvements, efficiencies, Innovation Quality Productivity (IQP).
•Maintains an “audit ready” module.
Keywords: bsc, biological safety cabinet, hood, aseptic, cell culture, cell therapy, T-cell, blood, gmp, cGMP
Position will be filled at level commensurate with experience.
Bachelor’s degree in relevant Engineering or Scientific discipline (preferred) or equivalent work experience. Advanced degree is a plus.
Fluent in speaking / writing in English.
•2-5 years of experience in cGMP cell culture manufacturing / experience in cell therapy manufacturing preferred.
•Thawing cryo-preserved product.
•Aseptic processing in ISO 5 biosafety cabinets.
•Universal precautions for handling human derived materials in BSL-2 containment areas.
•Cell expansion using incubators and single use bioreactors.
•Cell washing processes and automated equipment.
•Cell separation techniques and automated equipment.
•Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
•Experience with SAP, MES, Trackwise, etc. preferred.
•Alternate shifts, weekends and overtime will be required.
•Ability to work with magnetic field equipment.
•Ability to lift 50 lbs. unassisted.
•Requires handling of chemicals such as corrosives, solvents & bio-hazardous materials.
Please visit our website at www.novartis.com