Description

Job Description Summary
#LI-Onsite

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.

Job Description

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: Tues-Sat, AM Shift (6am-2:30pm).

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.
• 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.

*This role is located on-site in Morris Plains, NJ and will not have the ability to be located remotely. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, 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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range
$52,400.00 - $97,400.00

Skills Desired