Key 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:  Tuesday-Saturday, AM Shift.  6:00am-2:30pm

Essential 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. The use of corrective lenses to achieve the desired visual acuity is permitted.
• 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 preferred.
• Experience with Aseptic processing in ISO 5 biosafety cabinet.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $25.20 and $46.82 per hour. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

Company will not sponsor visas for this position.