1 purpose! Novartis expands its early development and innovative CAR-T cell therapy manufacturing capabilities in its newly launched Center of Excellence, located in the East Hanover, NJ campus. Our therapies are being developed as transformative treatments with life-saving potential for various B cell malignancies and other oncological diseases. We look to be bold with purpose, as we reimagine medicine and lead the way in advancing scientific breakthroughs for patients.
The Associate Expert, Drug Supply is responsible for cell production of patient derived clinical cellular immunotherapy products by functioning as both operator and verifier. Associate Expert, Drug Supply will also be responsible for the formulation and verification of all media. 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.
Your responsibilities include, but not limited to:
* Ownership for the processing of the assigned Patient starting material in the clean room environment to cryopreservation * Ability to gown aseptically and work in a clean room environment (Grades A-C) areas for extended periods of time * Executing production batch records utilizing both manual and automated equipment with high level of integrity * Verification of manufacturing processing include competency with automated cell production equipment 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 ME * Documents all steps in the assigned batch record in line with GMP requirements, following ALCOA+ principles * Conduct all necessary processing/verification steps for the assigned lot with highest skill level of aseptic technique * Conduct all necessary processing/verification steps for media with the highest skill level of aseptic technique * Cryopreservation of Final Product * Independently own/Assist on Deviation Investigations and Inspections * Drive and/or assist in implementation and closure of change requests * Revise/author/review/approve production related documents as needed * Proactively participates in team meetings, while maintaining a curious mindset * Ability to learn and adapt to multiple manufacturing processes * Participation in assigned 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 * Maintains an "audit ready" module * Perform other duties as assigned; ie. batch record review, process streamline improvements, safety walk-thru