#LI-Onsite
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.
About the RoleKey Responsibilities: Ability to aseptically gown and work in ISO 8, 7, and 5 cleanroom environments and stand for extended periods. Skilled in cell washing 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.Executes processing/verification of media lots with top-level aseptic technique and performs routine and dynamic environmental monitoring.Assists in Deviation Investigations, Inspections, and participates in 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.Requires handling of chemicals such as corrosives, solvents & bio-hazardous materials.Shift: The shift for this role will be 2nd Shift, Sunday-Thursday or Tuesday-Saturday. Ability to work different shifts, weekends and overtime will be required. Your shift will be fixed according to business need.
Minimum Requirements: HS diploma or GED required. A minimum of 1 year experience in cGMP, academic, or lab setting with aseptic experience.Associate degree or bachelor's 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.Ability to work with magnetic field equipment.Ability to lift 50 lbs., assisted.Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.Knowledge of universal precautions for handling human derived materials in BSL-2 containment areas.Experience in cell therapy manufacturing preferred.Experience with aseptic processing in ISO 5 biosafety cabinet.Company will not sponsor visas for this position. 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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives.
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The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives.
Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.
Division: Operations
Business Unit: Innovative Medicines
Location: USA
Site: Morris Plains
Company / Legal Entity: U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
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