Sep 15, 2022

Job Description

12,000. The number of associates worldwide working together to reimagine medicine!

The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines..

The Senior Expert, Science & Technology - Lab Systems, responsible for the lifecycle management of GxP lab systems in the Gene Therapy (GTx) analytical labs in Novartis Technical Research & Development (TRD) from concept, development, validation, implementation and maintenance to retirement.

• Acts as the SME for GxP lab systems such as LIMS, Empower, and other analytical instruments in the analytical labs in TRD GTx.
• 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.
• Plans and leads large GxP system projects, such as LIMS implementation and lab instrument qualification.
• Works with Development Quality, 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.
• Leads data integrity initiatives 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.
• Other related duties as assigned.

Vaccine Policy: While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

Bachelor’s degree in a Scientific, Biotech, Pharmaceutical or IT field with 8 years’ relevant experience working in a GxP pharma or biotech environment.
3 years instrument administration experience.
3 years’ experience with LIMS administration
3 years’ experience with chromatography data systems, especially Waters Empower®.
Advanced working knowledge of Windows permission settings, network domain, and a general understanding of server architecture is a plus
Working knowledge in SQL, Java, or other LIMS programming language.
Experienced in lifecycle management of GxP lab systems.
Up to 10% travel.

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

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 in order to perform the essential functions of a position, please send an e-mail to [email protected] 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.
Global Drug Development
San Diego, CA
Research & Development
Full Time
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Senior Expert, Science & Technology - LIMS Administrator

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