Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. Novartis recently received the first ever FDA approval for a CAR-T cell therapy for children and young adults with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or has relapsed at least twice; a novel immunocellular therapy, a one-time treatment that uses a patient's own T cells to fight cancer, and is the first therapy based on gene transfer approved by the FDA. Therapy will be manufactured for individual patients using their own cells at the Novartis Morris Plains, New Jersey facility where Novartis continues to advance its CAR-T manufacturing expertise. The Morris Plains site plans to hire over 300 Quality, Production, Supply Chain and Bioanalytics associates in the next 10-12 months.
Due to the nature of the starting materials (patient cells) the Cell processing Specialist role requires the highest level of proficiency and ownership. The Specialist will be responsible for end to end processing and verification of patient derived clinical and commercial cellular immunotherapy products.
Specific responsibilities will include:
- End to end ownership for the processing of the assigned patient starting material in the clean room environment.
- Maintain and prepare equipment/environment for use.
- Document all steps in the assigned Batch record in line with GMP requirements.
- Conduct all necessary processing/verification steps for the assigned lot with the highest skill level of aseptic technique.
- Assist on Deviation Investigations, Change Controls, Safety Inspections and CAPAs.
- Perform execution of assigned qualification/ validation activities.
- Be responsible for successful on time completion of a required training curriculum composed of Global Operating Procedures (GOPs), Standard Operating Procedures (SOPs), Aseptic Techniques, Gowning Qualifications and other relevant training, including HSE for the specific role.
- Perform other duties as assigned. Examples might be: successful completion of assigned PU project initiatives and/or work stream tasks, such as process improvements, efficiencies, Innovation Quality Productivity (IQP).
- Maintain an "audit ready" module.
Selected associates must:
- Be able to gown aseptically and work in a clean room environment (ISO 8, 7 and ISO 5) area for extended periods of time.
- Be able to work with automated cell processing equipment such as Elutra, CS5, or Sepax.
- Be knowledgeable in the use of production related IT systems such as SAP and MES.
- Possess sound cell biological decision making.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
- Bachelor’s degree in relevant Engineering or Scientific discipline (preferred) or equivalent work experience. Advanced degree desired.
- 2-5 years’ experience in cGMP cell culture manufacturing, experience in cell therapy manufacturing preferred.
- Expertise in:
- 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, cell separation techniques and use of automated equipment.
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
- Experience with SAP, MES, Trackwise, etc. preferred
- Fluency in written and spoken English.
- Ability to work a flexible shift is required.
Job Type: Full-time