Job Description Summary

The Cell Processing Specialist I is responsible for cell washing operations and also for verifying cell processing associates on 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.

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you

Job Description

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 such as the CS5
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
Assist on Deviation Investigations and Inspections and 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.

Requirements:

Associate degree or bachelor's degree in relevant Engineering or Scientific discipline required with a minimum of 6 months experience in cGMP or academic or lab setting with aseptic experience. If no degree, a minimum of 1 year experience in cGMP or academic or lab setting with aseptic experience.
Experience in cell therapy manufacturing preferred.
Ability to perform complex calculations and an understanding of scientific notations required
Preferred experience in Aseptic processing in ISO 5 biosafety cabinets.
Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
Ability to work different shift, weekends and overtime will be required. Your shift will be fixed according to business need.
Ability to lift 50 lbs unassisted and handling of chemicals such as corrosives, solvents & bio-hazardous materials.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:

https://www.novartis.com/about/strategy/people-and-culture.

The pay range for this position at commencement of employment is expected to be between $28.80 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 can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

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

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

Salary Range

$59,900.00 - $89,900.00

Skills Desired

Assembly Language (ASM), Cooperation, Efficiency, Electronic Components, Flexibility, General Hse Knowledge , Good Documentation Practice, Installations (Computer Programs), Iso (International Organization For Standardization), Job Description, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Processes, Manufacturing Production, Nuclear Medicine, Physics, Product Distribution, Production Lines, Workforce Planning