Job Description
<b>Job Description Summary</b>Location: East Hanover, NJ, United States (On-site)<br>LI #onsite <br>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 seeking a dynamic and visionary Associate Director to spearhead our Cell and Gene Therapy Analytical Operations Microbiology group. This pivotal role is not just about leading a team; it's about shaping the future of cell and gene therapy.<br>As the Associate Director of the Microbiology group, you'll be at the forefront of our mission, guiding a talented group of Quality Control Microbiology analysts dedicated to routine testing and microbiology method qualification for Novartis Cell and Gene products in the clinical phase. Additionally, you will oversee environmental monitoring activities for the Pilot Plant manufacturing facilities. Reporting to the Head of Cell and Gene Therapy Analytical Operations, you will be a vital link among Analytical Development, Pilot Plant manufacturing, Quality Assurance and Technical Operations.<br> <b>Job Description</b><b>Key Responsibilities:</b><ul><li>Lead and manage a team of Quality Control Microbiology analysts to perform routine product release and stability testing for sterility and endotoxin for Novartis Cell and Gene products in the clinical phase.</li><li>Oversee shift work, manage the environmental monitoring program, and coordinate the activities and priorities of the assigned team to meet the required business timelines. Serve as the primary point of contact for communication to management during shifts.</li><li>Lead microbiology method qualification, validation and transfer activities, including study design, reviewing, and approving study protocols and reports.</li><li>Develop strategies for microbiology method trending and routinely monitor assay performance to ensure data integrity and consistency.</li><li>Organize, plan, and support team members with technical questions and problem-solving to ensure group efficiency and accountability. Mentor and coach team members, facilitating career growth and professional development.</li><li>Ensure compliance with current Good Manufacturing Practices (cGMP), as well as Health, Safety, and Environmental policies per global and local Novartis standards.</li><li>Lead and perform Out-of-Specification (OOS) and Out-of-Expectation (OOE) investigations. Manage change controls, deviations, and Corrective and Preventative Action (CAPA) implementation.</li><li>Support laboratory inspections and audits, including addressing follow-up actions and ensuring continuous improvement.</li><li>Plan and manage resources and budget, including capital expenditure (CapEx) requirements.</li><li>Manage and support external vendor management activities to ensure the quality and compliance of external services and supplies.</li><li>Collaborate closely with cross-functional teams, including Manufacturing, Quality Assurance, Regulatory CMC, and Analytical Development, to ensure alignment and effective communication of quality control activities.</li><li>Stay abreast of industry trends, regulatory updates, and advancements in microbiological testing technologies, providing technical expertise and leadership to drive continuous improvement and innovation.</li></ul><b>Requirements:</b><ul><li>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.</li><li>Flexibility to work different shifts, weekends, and overtime, as required by business needs.</li><li>Extensive knowledge and experience of Cell and Gene Therapy Quality Control methods and compendial requirements (Sterility, Endotoxin, Environmental monitoring, APV/APS processes)</li><li>Extensive experience working in a GMP environment.</li><li>Strong communication, scientific writing, and