Expert Science & Technology - Quality Control, Information Technology

Novartis • East Hanover, NJ

102d • $77,000 - $143,000

About The Position

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 supports the management of data, analytical equipment and computerized system specialist. Your Role: As the Expert Science & Technology you are responsible to support maintain, update and troubleshoot the GMP analytical equipments 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. This position will be located at East Hanover site and will not have the ability to be located remotely.

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.

Nice To Haves

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

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.

Benefits

• The pay range for this position at commencement of employment is expected to be between $77,000-$143,000.
• The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree