Job Description Summary

Location: East Hanover, NJ, United States. Position will be onsite
Internal Title: Expert Science & Technology
Join Our Vision: At Novartis, we are on a transformative journey in cell and gene therapy, pushing the boundaries of medical innovation. We are currently looking for an Expert Science & Technology to join our team and help us deliver high-quality solutions that support the management of data, analytical equipment, and computerized system specialist.

Your Role: As the Expert Science & Technology, you are responsible for supporting, maintaining, updating, and troubleshooting the GMP analytical equipment related items for Cell and Gene Therapies. Additionally, the Expert will assist with site projects such as system updates and/or enhancements within tight timelines following guidelines and compliance. Knowledge of GxP regulations is recommended.

Key Responsibilities:

• Acts as the SME for GxP lab systems for all analytical instruments in the analytical labs in TRD CGT such as Flow cytometer, ddPCR, UPL, NGS, Empower, etc.
• Ensures the GxP lab systems are in compliance with all regulatory requirements such as 21 CFR Part 11 and Annex 11.
• Day-to-day management and continuous improvement of all GxP lab systems/processes and supports data integrity initiatives related to GxP lab systems.
• Works with Analytical Development and Operation teams, IT, Engineering, and Validation to support GxP lab system lifecycle management activities from concept, development, validation, implementation, and maintenance to retirement.
• Authors, reviews, reports on, and approves corrective actions to protocols, investigations, non-conformance, CAPAs, and other records related to GxP lab systems.
• Reviews, identifies, and leads the implementation of improvements to existing lab systems. Oversees/Creates SOPs and training related to GxP lab systems.
• Leads representation of GxP lab systems during meetings. Oversees and/or communicates and tracks all follow-up items through to completion.
• Plans and leads large GxP system projects, such as LIMS implementation and lab instrument qualification. Other related duties as assigned.
• Position is Monday-Friday, but weekend support may be needed.

Requirements:

• Bachelor's degree is required. A degree in Biology, Biochemistry, Molecular Biology, Immunology, or related scientific discipline is preferred.
• A minimum of 3 years of industry experience in automation/digitalization projects and Pharmaceuticals.
• Experience in instrument administration, preferably in CGT.
• Strong knowledge of regulatory requirements and industry standards, including GxP, FDA 21 CFR Part 11, and EU Annex 11.
• Experience with validation lifecycle documentation, including URS, FRS, DS, IQ, OQ, PQ, and traceability matrices.
• Working knowledge in SQL, Java, or other LIMS programming language.
• Experienced in lifecycle management of GxP lab systems.

Desired Requirements:

• LIMS administration a plus.
• Experience working with AAV, LVV, and cell therapy analytics preferred.

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 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.