Associate Director of BioAnalytics, Cell and Gene Therapy Analytical Operations

$144,000 - $216,000/Yr

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

Full-time - Mid Level

East Hanover, NJ

About the position

The Associate Director of BioAnalytics at Novartis will lead the Cell and Gene Therapy Analytical Operations Bioanalytics group, focusing on routine testing, method qualification, and validation for clinical products. This role involves managing a team of Quality Control analysts and ensuring compliance with Good Manufacturing Practices while driving innovation in cell and gene therapy.

Responsibilities

• Lead and manage a team of Quality Control analysts for routine product release and stability testing.
• Oversee shift work and coordinate activities to meet business timelines.
• Serve as the primary point of contact for communication to management during shifts.
• Lead method qualification, validation, and transfer activities, including study design and protocol approval.
• Develop strategies for analytical method trending and monitor assay performance.
• Organize and support team members with analytical/technical questions and problem-solving.
• Mentor and coach team members to facilitate career growth.
• Ensure compliance with Good Manufacturing Practices and Health, Safety, and Environmental policies.
• Lead OOS/OOE investigations and manage change controls, deviations, and CAPA implementation.
• Support laboratory inspections and audits, including follow-up actions.
• Plan and manage resources and budget, including capital expenditures.

Requirements

• BS with a minimum of 8 years of industry experience in biotech or pharmaceutical companies.
• At least 4 years of direct people management experience in a Quality Control environment.
• Flexibility to work different shifts, weekends, and overtime as required.
• Extensive knowledge of Cell and Gene Therapy Quality Control methods including molecular assays, Flow Cytometry, potency assays, and liquid chromatography.
• Extensive experience working in a GMP environment.
• Strong communication, scientific writing, and presentation skills.

Nice-to-haves

• Experience in resource and budget management.
• Experience with electronic systems such as SAP, LIMS, and Quality Management Systems.

Benefits

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