Paul Nucero

Associate Director, Quality Engineering (Team Lead) @Bristol Myers Squibb

Warren, NJ, US

Lead the Quality Engineering team, which provides oversight of all qualification, validation and technology transfer activities at the Cell Therapy Warren site (material for first-in-human Phase I, pivotal Phase II and Phase trials for autologous and allogeneic cell therapy programs)-Quality oversight of technology transfer activities into and out of the site and ensures compliance with global and regulatory requirements-Establish processes to ensure accurate and timely maintenance and review of validation and qualification documents for all IT, equipment, utility and facility activities-Accurate and timely review of technically complex technology transfer-related discrepancies, change controls, batch record documentation, process protocols, and manufacturing documentation-Ensures that process and method transfers, method qualifications/verifications, and operator/analyst trainings meet company and regulatory requirements-Support of the site’s data integrity initiatives and quality risk management program-Manage a team of six employees (FTEs and contractors) which includes ensuring objectives are met on a timely basis, establishing and monitoring of goals and development plan, and executing cross-training initiatives.