Summary
This position will be located at East Hanover, NJ site and will not have the ability to be located remotely. This position will require minimal travel as defined by the business.
The Associate Expert Drug Supply is responsible for production of patient derived clinical cellular immunotherapy products by functioning as both operator and verifier. Associate Expert Drug Supply will also be responsible for the formulation and verification of all media. 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 Key Responsibilities:
• Ownership for the processing of assigned clinical batches in the cleanroom environment through cryopreservation.
• Ability to gown aseptically and work in a cleanroom environment (Grades A-C) areas for extended periods of time.
• Execution of production batch records utilizing both manual and automated equipment with high level of integrity.
• Verification of manufacturing processing, including competency with automated cell production equipment 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 cGMP requirements, following ALCOA+ principles.
• Independently own/assist on deviation investigations and inspections.
• Drive and/or assist in assessment, implementation, and closure of change requests.
• Revise/author/review/approve production related documents as needed.
• Proactively participates in team meetings, while maintaining a curious mindset.
About the Role
- Bachelor’s degree in relevant scientific discipline required with a minimum of 1 year experience in cGMP or academic or lab setting with aseptic or cell culture experience. If no degree, a minimum of 2 years’ experience in cGMP setting with aseptic or cell culture experience
- Experience in cell therapy manufacturing preferred.
- Ability to adapt and learn new systems.
- Ability to perform manual calculations
- Ability to collaborate with other groups, teams, and departments in addressing inventory related issues.
- Speak Up Mentality.
- Demonstrate a high level of discipline and self-motivation. · Maintains composure during stressful situations
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $66,000 -$99,000 annually; 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.
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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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 & 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 [email protected] 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.
