Job Description Summary
This role is located on-site in Morris Plains, NJ. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives.
The Cell Processing Specialist is responsible for cell washing operations and verifying cell processing intermediate processing days of patient-derived clinical and commercial cellular immunotherapy products. The CPS I 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 a high level of proficiency and ownership of the process and media formulation.
Key Responsibilities:
- Ability to gown aseptically and work in a clean room environment (ISO 8, 7 and ISO 5) areas for extended periods of time. Cell washing with the ability to work with automated equipment.
- 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 the highest skill level of aseptic technique.
- Conducts routine and dynamic environmental monitoring as required.
- Assist on Deviation Investigations and Inspections and 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.
Additional Specifications:
- Ability to work different shifts, 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., assisted.
- Ability to stand for an extended period of time.
- Requires handling of chemicals such as corrosives, solvents & bio-hazardous materials.
Essential Requirements:
- HS diploma or GED required. A minimum of 1 year experience in cGMP, academic, or lab setting with aseptic experience.
- Associates degree or Bachelors degree in relevant Engineering or Scientific discipline may be considered in lieu of industry 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. Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
EEO Statement: 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 other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to ...@novartis.com or call +1 (877)###-####.
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