Job Description Summary

#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.

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: The shift for this role will be 1st 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.

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.
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.

The pay range for this position at commencement of employment is expected to be between $28.37 to $43.22/hour; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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.

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. 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. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.

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

$59,900.00 - $89,900.00

Skills Desired