Cell Processing Specialist CAR-T Cell Therapy (multiple openings) job in Morris Plains
|Employer:|| Novartis Pharmaceuticals|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
Cell Processing Specialist CAR-T Cell Therapy - Morris Plains, NJ (multiple positions available)|
927 million. That's how many lives our products touched in 2017. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks. And where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
We are Novartis. Join us and help reimagine medicine.
The Cell Processing Specialist is responsible for operations on Day 0, cell washing and Harvest processing and for verifying cell processing associates on intermediate processing days of patient derived clinical and commercial cellular immunotherapy products.
Cell processing specialist 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.
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
Day 0, cell washing and Harvest processing with the ability to work with automated equipment such as the CS5 and Sepax
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
Conduct all necessary processing/verification steps for assigned lots of media with the highest skill level of aseptic technique
Assist on Deviation Investigations and Inspections
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-thrus
Key Performance Indicators:
Right First Time Batch Record execution
Conformance to schedule
95% training compliance of all associates
Adherence to attendance guidelines and all safety related procedures
No major or critical audit findings pertinent to the ISO 5 & 7 areas
Manufacturing compliance/adherent to all GDP/GMP principles
Aseptic/Cleanroom behavior in accordance with GMP guidelines\n\n\n\nPosition will be filled at level commensurate with experience.
Bachelor's degree in relevant Engineering or Scientific discipline required with a minimum of 1 year experience in cGMP or academic or lab setting with aseptic or cell culture experience. If no degree, a minimum of 2 years' experience in cGMP or academic or lab setting with aseptic or cell culture 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.
•Cell expansion using incubators and single use bioreactors.
•Cell automated equipment.
•Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
Other preferred Qualifications:
•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.
•Requires handling of chemicals such as corrosives, solvents & bio-hazardous materials.
•Ability to adapt and learn new and complex equipment and systems and detailed scientific content.
•Ability to collaborate with other groups, teams and departments in addressing process related issues in a highly diverse environment.