Associate Director of Microbiology, Cell & 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 the Cell and Gene Therapy Analytical Operations Microbiology group at Novartis is a leadership role focused on guiding a team of Quality Control Microbiology analysts. This position is pivotal in ensuring the quality and compliance of microbiological testing for Novartis Cell and Gene products in the clinical phase, overseeing routine testing, method qualification, and environmental monitoring activities. The role requires collaboration across various departments to maintain high standards of quality control and drive continuous improvement in microbiological testing methodologies.

Responsibilities

• Lead and manage a team of Quality Control Microbiology analysts for routine product release and stability testing.
• Oversee shift work and manage the environmental monitoring program.
• Serve as the primary point of contact for communication to management during shifts.
• Lead microbiology method qualification, validation, and transfer activities.
• Develop strategies for microbiology method trending and monitor assay performance.
• Organize and support team members with technical questions and problem-solving.
• Mentor and coach team members for career growth and professional development.
• Ensure compliance with current Good Manufacturing Practices (cGMP) and Health, Safety, and Environmental policies.
• Lead and perform Out-of-Specification (OOS) and Out-of-Expectation (OOE) investigations.
• Manage change controls, deviations, and Corrective and Preventative Action (CAPA) implementation.
• Support laboratory inspections and audits, ensuring continuous improvement.
• Plan and manage resources and budget, including capital expenditure (CapEx) requirements.
• Manage and support external vendor management activities.
• Collaborate with cross-functional teams to ensure alignment and effective communication of quality control activities.
• Stay updated on industry trends and advancements in microbiological testing technologies.

Requirements

• BS with a minimum of 8 years of industry experience in Microbiology in biotech or pharmaceutical companies.
• Minimum of 4 years of direct people management experience in a Quality Control environment.
• Flexibility to work different shifts, weekends, and overtime as required.
• Extensive knowledge and experience of Cell and Gene Therapy Quality Control methods and compendial requirements.
• 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

• Comprehensive medical, financial, and other benefits including 401(k) eligibility and various paid time off benefits.
• Potential for a sign-on bonus and restricted stock units.
• Discretionary awards based on performance.