Novartis · 2 weeks ago
Expert Science & Technology - Quality Control, Information Technology
East Hanover, NJ
Full-time
Onsite
Mid Level
$77K/yr - $143K/yr
3+ years expNovartis is on a transformative journey in cell and gene therapy, and they are seeking an Expert Science & Technology to join their team. The role focuses on maintaining and troubleshooting GMP analytical equipment, supporting site projects, and ensuring compliance with regulatory requirements.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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 to 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 implementation of improvements to existing lab systems. Overseas/Creates SOPs and training related to GxP lab systems
Lead 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 a Monday-Friday, but weekend support may be needed
Qualification
Required
Bachelors degree is required
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
Preferred
A degree in Biology, Biochemistry, Molecular Biology, Immunology or related scientific discipline is preferred
LIMS administration a plus
Experience working with AAV, LVV and cell therapy analytics preferred
Benefits
Sign-on bonus
Restricted stock units
Discretionary awards
Full range of medical benefits
Financial benefits
401(k) eligibility
Various paid time off benefits
Vacation
Sick time
Parental leave
Company
Novartis
Novartis is a pharmaceutical company that researches and develops medicines for serious diseases to improve and extend people's lives.
10001+ employees
H1B Sponsorship
Novartis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (27)
2023 (23)
2022 (27)
2021 (31)
2020 (25)
Funding
Current Stage
Public CompanyTotal Funding
$2.49BKey Investors
Bill & Melinda Gates Foundation
2024-06-19Post Ipo Debt· $2.49B
2018-02-14Grant· $6.5M
2000-05-19IPO
Leadership Team
Daniel Grant
Vice President & Global Program Head
John von Brachel
VP, Head of Content Lab
Recent News
South China Morning Post
2026-01-14
Pharmaceutical Technology
2026-01-13
Company data provided by crunchbase