Job Description Summary

Novartis expands its early development and innovative CAR-T cell therapy manufacturing capabilities in its newly launched Center of Excellence, located in the East Hanover, NJ campus. Our therapies are being developed as transformative treatments with life-saving potential for various B cell malignancies and other oncological diseases. We look to be bold with purpose, as we reimagine medicine and lead the way in advancing scientific breakthroughs for patients.

The Expert, Science & Technology will be assigned operational activities within the remit of the department such as clinical program support, patient safety, or OpEx. Individually contribute to and support all GxP activities in the department. Administers Quality Systems and processes (including documentation, metrics and monitoring of actions). Supports establishment of Quality operational processes. Performs routine GxP Compliance/ Operational activities according to Novartis Quality Standards. Supports Quality Projects and initiatives. Learn and grow into the next role. Under general direction, perform bioanalytical testing and other activities in functions supporting the Quality Control department.

Job Description

Key responsibilities include, but are not limited to:

**Shift position** Shift: Tues- Friday and weekend coverage as needed 10 hour shift 10am -8pm. Shift will be fixed according to business need.
Perform bioanalytical testing and support activities compliantly following appropriate 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 execution of method qualification/development & optimization/transfer as governed by protocols and/or under the supervision.
Train other associates in specific areas of competency.
Lead and/or contribute to writing CAPAs/OOS/OOE/OOT and perform deviation investigations.
Support change control as required.
Support 5S and Lean projects.
Knowledge of LabWare, LIMS and/or other QC data systems.
Knowledge of appropriate GMP/GLP quality systems (ESOPs, Trackwise, BMRAM, etc.).
Interface with regulatory agencies during audits as required.
In addition to these primary duties, provide coverage for all appropriate areas.

Minimum Requirements:

Bachelors degree is required. A degree in science is preferred. Advanced degree may be an advantage but not essential.
Minimum 3 years of experience in the pharmaceutical, biologics, Biotechnology, or medical device industry, ideally in a QC laboratory setting.
Thorough knowledge of bioassay test methods (Elisa, flow cytometry, qPCR, cell culture) is required.
Strong written and verbal communication skills are essential.
Experienced in the use of computer -based systems and applications.

Desired Requirements:

Good understanding of the concepts of cGxP and knowledge of ICH, Eur. Ph., USP and FDA and JP guidelines is preferred.
Experience in support/writing OOS/OOE/OOT and/or deviation investigations and knowledge of CAPA is preferred.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between: $77,000-$143,000/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, 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.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. 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.

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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@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.

Salary Range

$77,000.00 - $143,000.00

Skills Desired

Agility, Audit Management, Business Partnering, Change Control, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Quality Management Systems (QMS), Risk Management, Root Cause Analysis (RCA), Self-Awareness, Sop (Standard Operating Procedure), Technological Expertise