Job ID286618BRPosition TitleCell /Media Processing AssociateApply to Job
Job Description
The Cell Processing Associate is responsible for intermediate processing of patient derived clinical and commercial cellular immunotherapy products. Due to the nature of the starting material (patient cells) this role requires basic proficiency and ownership of the process.• Intermediate ownership for the processing of the assigned Patient starting material in the clean room environment. o Ability to gown aseptically and work in a clean room environment (ISO 8, 7 and ISO 5) areas for extended periods of time. o Maintains and prepares equipment/environment for use o Ability to work with automated cell processing equipment such as the wave bioreactor. o Ability to perform in process operations such as: bioreactor sampling, static sampling and in process environmental monitoring o Knowledgeable in the use of production related IT systems such as SAP and MES o Documents all steps in the assigned Batch record in line with GMP requirements o Conduct all necessary processing steps for the assigned lot with highest skill level of aseptic technique. Assist on deviation investigations and inspections Participation in assigned qualification/ validation activities, as necessary 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. Maintains an “audit ready” module Perform other duties as assigned; ie. batch record review, process streamline improvements, safety walk-thrus
Minimum requirements
Bachelor’s degree in relevant Engineering or Scientific discipline. If no degree, a minimum of 1 year experience in cGMP or aseptic or cell culture environment required. German - English advantages • Experience in cell therapy manufacturing preferred • Experience desired in o Universal precautions for handling human derived materials in BSL-2 containment areas. o Cell expansion using incubators and single use bioreactors. o Cell automated equipment. o Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.DivisionNovartis Technical OperationsBusiness UnitNTO CELL & GENE THERAPYLocationSwitzerlandSiteStein (Säckingen)Company/Legal EntityNovartis Pharma AGFunctional AreaTechnical OperationsJob TypeFull TimeEmployment TypeRegular
