Expert Science & Technology, Quality Control (2nd Shift Tuesday-Friday)
Job ID: REQ-10048022
Date: Apr 14, 2025
Location: USA
Summary:
Internal Title: Expert Science & Technology
This role is based at the East Hanover, NJ site and does not offer remote or relocation options. Only local candidates will be considered.
This is a shift-based position: Tuesday to Friday, 10-hour shifts from 10:00 AM to 8:00 PM, with weekend coverage as needed.
Novartis is expanding its early development and CAR-T cell therapy manufacturing capabilities at the East Hanover, NJ Center of Excellence. The therapies developed aim to transform treatments for B cell malignancies and other oncological diseases.
The Expert, Science & Technology will support operational activities in clinical program support, patient safety, and operational excellence (OpEx). They will contribute individually to GxP activities, administer Quality Systems and processes, support Quality Projects, and perform bioanalytical testing for the Quality Control department.
About the Role:
Key Responsibilities:
Perform bioanalytical testing and support activities following SOPs and procedures.
Peer review and archive analytical data in lab documentation systems.
Draft, finalize, and revise technical protocols, procedures, and reports with minimal supervision.
Support method qualification, development, optimization, and transfer under protocols or supervision.
Train associates in specific areas of competency.
Lead and/or contribute to writing CAPAs, OOS, OOE, and OOT reports and perform deviation investigations.
Support change control activities.
Contribute to 5S and Lean projects.
Utilize LabWare, LIMS, and other QC data systems.
Ensure adherence to GMP/GLP systems (ESOPs, Trackwise, BMRAM).
Interface with regulatory agencies during audits as needed.
Provide cross-coverage for appropriate operational areas.
Minimum Requirements:
Bachelor’s degree required; science degree preferred.
Minimum 3 years’ experience in pharmaceutical, biologics, biotechnology, or medical device industries, ideally in a QC laboratory.
Thorough knowledge of bioassay test methods including ELISA, flow cytometry, qPCR, and cell culture.
Strong written and verbal communication skills.
Experienced in computer-based systems and applications.
Desired Requirements:
Good understanding of cGxP concepts and knowledge of ICH, Eur. Ph., USP, FDA, and JP guidelines.
Experience in supporting/writing OOS, OOE, OOT reports and deviation investigations, with knowledge of CAPA processes.
Novartis Compensation and Benefits Summary:
Salary range: $77,000 - $143,000/year (subject to adjustment based on market conditions and individual qualifications).
May include sign-on bonuses, restricted stock units, discretionary awards, and a comprehensive benefits package (medical, financial, 401(k), and various paid time off benefits).
Why Novartis:
At Novartis, we combine innovation, passion, and collaboration to create transformative treatments for patients.
Learn more: Novartis Strategy, People and Culture
Join Our Network:
Stay connected: Novartis Talent Network
Benefits and Rewards:
Learn more: Novartis Benefits and Rewards
Equal Opportunity Employer Statement:
Novartis is an Equal Opportunity Employer and does not discriminate based on race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or other legally protected statuses.
Accessibility and Reasonable Accommodations:
For accommodations due to disability or medical conditions, email: us.reasonableaccommodations@novartis.com or call +1(877)395-2339 with the job requisition number.
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