395292BR
Mar 28, 2024
USA
About the Role
Location: Morris Plains, NJ. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
About the role:
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 I 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.
Key Responsibilities:
• Ownership for the processing of the assigned Patient starting material 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 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. Conducts routine and dynamic environmental monitoring as required.
• 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.
• Assist on Deviation Investigations and Inspections. Participation in assigned qualification/ validation activities. Perform other duties as assigned, ie. batch record review, process streamline improvements, safety walk-throughs.
Additional Notes:
• 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.
About the role:
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 I 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.
Key Responsibilities:
• Ownership for the processing of the assigned Patient starting material 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 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. Conducts routine and dynamic environmental monitoring as required.
• 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.
• Assist on Deviation Investigations and Inspections. Participation in assigned qualification/ validation activities. Perform other duties as assigned, ie. batch record review, process streamline improvements, safety walk-throughs.
Additional Notes:
• 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.
Diversity & Inclusion / EEO
We 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: 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 let us know the nature of your request, your contact information and the job requisition number in your message:
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 let us know the nature of your request, your contact information and the job requisition number in your message:
- Novartis: e-mail [email protected] or call +1 (877)395-2339
- Sandoz: e-mail [email protected] or call: +1-609-422-4098
Role 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.
• 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.
Pay transparency statement: The pay range for this position at commencement of employment is expected to be between $28.37 and $43.22/hourly; 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.
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
• 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.
Pay transparency statement: The pay range for this position at commencement of employment is expected to be between $28.37 and $43.22/hourly; 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.
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
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Operations
CELL & GENE THERAPY
USA
Morris Plains, NJ
Novartis Pharmaceuticals
Technical Operations
Full Time
Regular
Yes
