Senior Manager, Equipment and LIMS, Cell and Gene Therapy Analytical Operations

U014 (FCRS = US014) Novartis Pharmaceuticals Corporation • East Hanover, NJ

392d • $112,800 - $169,200

About The Position

The Sr. Manager for Cell and Gene Therapy Analytical Operations Equipment and LIMS at Novartis is a leadership role focused on enhancing the digital landscape supporting Quality Control (QC) laboratories for cell and gene therapy products. This position involves managing a team of analysts, overseeing the implementation and improvement of systems, and ensuring compliance with regulatory standards. The role is pivotal in shaping the strategic vision for QC digital operations and requires collaboration across various departments to support clinical product development.

Requirements

• BS with a minimum of 6 years of industry experience in biotech or pharmaceutical companies.
• At least 2 years of direct people management experience in QC digitalization projects.
• Excellent understanding of cGXP requirements and good documentation practices related to systems, equipment, and instrumentation.
• Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance.
• Strong communication, writing, and presentation skills.

Nice To Haves

• Experience in resource and budget management.

Responsibilities

• Lead and manage a team of analysts to work closely with the Global GDLIMS team.
• Ensure the implementation of new systems and improvements of existing systems, including system configuration specification and administration.
• Shape and deliver the long-term strategic vision for the Quality Control Digital roadmap.
• Serve as the primary point of contact for communication with management.
• Oversee equipment qualifications and validation protocols, risk management tools, and validation exceptions/deviations for Computer and IT systems.
• Support initial and routine system risk assessment and testing activities.
• Organize, plan, and support team members with QC equipment or LIMS technical questions and problems.
• Mentor and coach team members to facilitate career growth.
• Ensure compliance with Good Manufacturing Practices and Health, Safety, and Environmental policies.
• Manage change controls, deviations, and CAPA implementation related to QC instruments or GDLIMS.
• Support laboratory inspections and audits, including follow-up actions.
• Plan and manage resources and budget, including capital expenditure.

Benefits

• 401(k) eligibility
• Paid time off benefits including vacation, sick time, and parental leave
• Sign-on bonus
• Restricted stock units
• Discretionary awards
• Comprehensive medical benefits

What This Job Offers

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