Associate Expert Science & Technology, Quality Control (Shift Position: Mon-Thurs)

Job Description Summary

Internal Job Title: Associate Expert Science & Technology- REQ-10013825
Position is on-site in East Hanover, NJ
#LI-Onsite

About the role:
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 Associate 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

Your Key Responsibilities:

Your responsibilities include, but are not limited to:

• **Shift position**  Shift: Monday-Thursday 8am-6pm. Shift will be fixed according to business need.
• Perform bioanalytical testing in support of clinical release strategies.
• Perform all testing and activities compliantly following appropriate SOPs and procedures.
• Maintain controls and reference standards to support testing.
• Executes and follows SOPs, WPs, and quality policies.
• Peer review and archive analytical data in lab documentation systems.
• Support monthly/quarterly laboratory cleaning.
• Manage reagent/consumable inventory and support equipment cleaning for assigned areas of responsibilities.
• Ensures cleanliness of laboratory working areas.
• Support and author OOS/OOE/OOT and deviation investigations.
• Participate in CAPA implementation in a timely manner.
• Follows GxP quality policies and procedures.
• Ensures all assigned training is completed within required time frame.
• Support 5S and Lean projects.
• Identify process improvements.
• Knowledge of LabWare, LIMS and/or other QC data systems.
• Knowledge of appropriate GMP/GLP quality systems (ESOPs, Trackwise, BMRAM, etc.).
• Support execution method qualification/optimization of methods.
• Interface with regulatory agencies during audits as required.
• In addition to these primary duties, provide coverage for all appropriate areas.
• Contributes to assigned projects by following pre-defined tasks and executing as instructed.
• Performs other job duties as assigned.

Role Requirements:

• Bachelors degree in cell biology, immunology, molecular biology, virology, biochemistry, microbiology, or other related science.
• At least 1 year of experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry, ideally in a QC laboratory setting.
• Understanding 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:

• Understanding of the concepts of cGxP is preferred
• Knowledge of CAPA is preferred
• experience with Root Cause Analysis (Rca) is preferred

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

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a dive