Cell Processing Specialist I, (Sun-Thurs, PM)

Novartis • Morris Plains, NJ

96d • $25 - $46

About The Position

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 high level of proficiency and ownership of the process and media formulation.

Requirements

• HS diploma or GED required.
• A minimum of 1 year experience in cGMP, academic, or lab setting with aseptic experience.
• Associate's 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.
• Near vision performance should be the equivalent of 20/20 with no impairment of color vision.
• 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.

Nice To Haves

• Experience in cell therapy manufacturing preferred.
• Experience with Aseptic processing in ISO 5 biosafety cabinet.

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.

Benefits

• Health, life and disability benefits.
• 401(k) with company contribution and match.
• Generous time off package including vacation, personal days, holidays and other leaves.
• Performance-based cash incentive.
• Eligibility for annual equity awards.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED