Cell Processing Specialist I, PM Shift

3 days ago


Morris Plains, New Jersey, United States Novartis Group Companies Full time
Job Description

Job Summary:

Novartis is seeking a highly skilled Cell Processing Specialist I to join our team in Morris Plains, NJ. As a key member of our cell therapy manufacturing team, you will be responsible for cell washing operations, verifying cell processing intermediate processing days, and formulating and verifying media lots.

Key Responsibilities:

  • Aseptically gown and work in ISO 8, 7, and 5 cleanroom environments, standing for extended periods.
  • Verify intermediate process days, including expertise with the wave bioreactor, NC-200, and in-process environmental monitoring.
  • Maintain and prepare equipment/environment for use, proficient in production-related IT systems such as SAP, LIMS, and MES.
  • Execute processing/verification of media lots with top-level aseptic technique and perform routine and dynamic environmental monitoring.
  • Assist in Deviation Investigations, Inspections, and participate in qualification/validation activities.
  • Responsible for successful on-time completion of required training curriculum, including Global Operating Procedures (GOPs), Standard Operating Procedures (SOPs), and Aseptic Techniques.
  • Handle chemicals such as corrosives, solvents, and bio-hazardous materials.

Requirements:

  • High School diploma or GED required; Associate degree or Bachelor's degree in a relevant Engineering or Scientific discipline may be considered in lieu of industry experience.
  • Minimum 1 year experience in cGMP, academic, or lab setting with aseptic experience.
  • Ability to perform complex calculations and understand scientific notations.
  • Ability to work with magnetic field equipment and 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.

Desirable Requirements:

  • Experience in cell therapy manufacturing and aseptic processing in ISO 5 biosafety cabinet.

What We Offer:

Competitive hourly rate, sign-on bonus, restricted stock units, and discretionary awards, as well as a full range of medical, financial, and other benefits, including 401(k) eligibility and paid time off benefits.

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 who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds, and perspectives.



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