388159BR

USA

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. The shift hours are 6:00am-2:30pm

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. Cell Processing Specialist 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.

Ownership for the processing of the assigned Patient in the clean room environment.

Ability to gown aseptically and work in a clean room environment (ISO 8, 7 and ISO 5) areas for extended periods of time. Cell washing with the ability to work 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.

Conduct all necessary processing/verification steps for the assigned lot with highest skill level of aseptic technique.

Conduct all necessary processing/verification steps for assigned lots of media with the highest skill level of aseptic technique.

Conducts routine and dynamic environmental monitoring as required.

Assist on Deviation Investigations and Inspections and participation in assigned 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.

Perform other duties as assigned, ie. batch record review, process streamline improvements, safety walk-throughs.

Additional Specifications:

Ability to work different shift, weekends and overtime will be required. Your shift will be fixed according to business need.

Ability to work with magnetic field equipment.

Ability to lift 50 lbs unassisted.

Ability to stand for an extended period of time

Requires handling of chemicals such as corrosives, solvents & bio-hazardous materials.

Ability to adapt and learn new and complex equipment and systems and detailed scientific content.

Ability to collaborate with other groups, teams and departments in addressing process related issues in a highly diverse environment.

HS diploma or GED required. A minimum of 1 year experience in cGMP or 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

Experience in cell therapy manufacturing preferred.

Experience desired in: Aseptic processing in ISO 5 biosafety cabinets.

Universal precautions for handling human derived materials in BSL-2 containment areas. Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.

The pay range for this position at commencement of employment is expected to be between $28.37 and $43.22/hourly; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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.

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards

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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Operations

CELL & GENE THERAPY

Morris Plains, NJ

Novartis Pharmaceuticals

Technical Operations

Full Time

Regular

No

Yes