Clinical Cell Processing Specialist job in East Hanover
|Employer:|| Novartis Pharmaceuticals|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
The Clinical Cell Processing Specialist is responsible for operations on Day 0, cell washing and Harvest processing and for verifying Cell Processing associates on intermediate processing day(s) of patient derived clinical cellular immunotherapy products. Clinical Cell Processing Specialist will also be responsible for the formulation and verification of all media lots. Furthermore, the Clinical Cell Processing Specialist will perform scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures in collaboration within a multifunctional project team coordinated by a project leader.
• 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 Day 0, cell washing and Harvest processing with the ability to work with automated equipment such as the CS5 and Sepax
o Verification of intermediate process days which include expertise with the wave bioreactor, NC-200 and in process environmental monitoring
o Maintains and prepares equipment/environment for use
o Proficient in the use of production related IT systems such as SAP, LIMS and MES
o Documents all steps in the assigned Batch record in line with GMP requirements
o Conduct all necessary processing/verification steps for the assigned lot with highest skill level of aseptic technique.
o Conduct all necessary processing/verification steps for assigned lots of media with the highest skill level of aseptic technique
• Perform scientific experiments and plan, perform and contribute to project related scientific/technical activities under minimal guidance from more experienced team members under guidance. (eg. contribute to interpretation and report results)
• Actively transfer procedures/instructions to pilot plant or production, including troubleshooting, process steering controls
• 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-thrusEducation: Bachelor's degree in relevant Engineering or Scientific discipline. Advanced degree preferred.
Languages: Fluent in speaking / writing in English
• 1-3 years of experience in cGMP in cell therapy manufacturing. Novartis Cell and Gene Therapy experience preferred.
• Experience in:
o Thawing cryo-preserved product
o Aseptic processing in ISO 5 biosafety cabinets.
o Universal precautions for handling human derived materials in BSL-2 containment areas.
o Cell expansion using incubators and single use bioreactors.
o Cell washing processes and automated equipment.
o Cell 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 may be required based on 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.
• Awareness/proven experience for safe handling of chemicals, potentially dangerous materials and equipment.