Expert Science & Technology - Quality Control, Information Technology

Job Description Summary

Job Description

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 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 leadsimplementation 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

Requirements:

• Bachelors 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.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $77,000-$143,000; 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

Skills Desired