Cell Processing Specialist I (PM Shift)

Role Details

367025BR Cell Processing Specialist I (PM Shift) Job Description 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 operating and verifying 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. The Cell Processing Specialist I is responsible for cell washing operations and 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. Your responsibilities include, but not limited to: *Ownership for the processing of the assigned Patient starting material in the clean room environment. oAbility to gown aseptically and work in a clean room environment (ISO 8, 7 and ISO 5) areas for extended periods of time. oCell washing with the ability to work with automated equipment such as the CS5 oVerification of intermediate process days which include expertise with the wave bioreactor, NC-200 and in process environmental monitoring oMaintains and prepares equipment/environment for use oProficient in the use of production related IT systems such as SAP, LIMS and MES oDocuments all steps in the assigned Batch record in line with GMP requirements oConduct all necessary processing/verification steps for the assigned lot with highest skill level of aseptic technique. oConduct all necessary processing/verification steps for assigned lots of media with the highest skill level of aseptic technique oConducts routine and dynamic environmental monitoring as required *Assist on Deviation Investigations and Inspections *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 Other Qualifications: *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. ***Multiple positions available. The shifts we are hiring for are as follows: * Sun-Thurs PM (1pm-9:30pm) * Tues-Sat PM (1pm-9:30pm) 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. Minimum requirements What you'll bring to the role: *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 Desirables: *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. Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. Other Qualifications: *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 stand for an extended period of time *Ability to lift 50 lbs unassisted. *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. Why Novartis? 766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!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.Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to tas.nacomms@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.The pay range for this position at commencement of employment is expected to be between $59,900 and $89,900 per year; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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 Division Novartis Technical Operations Business Unit CELL & GENE THERAPY Country USA Work Location Morris Plains, NJ Company/Legal Entity Novartis Pharmaceuticals Functional Area Technical Operations Job Type Full Time Employment Type Regular Shift Work Yes Early Talent Yes 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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Novartis Services Incorporated provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.