Thomas Rosiere serves as a Principal Scientist in Product Development at Abbott Laboratories, specifically within the Diagnostic Division, where he leverages his extensive expertise in technical operations and new product development to drive innovation in the field of in vitro diagnostics (IVD). With a strong...
Thomas Rosiere serves as a Principal Scientist in Product Development at Abbott Laboratories, specifically within the Diagnostic Division, where he leverages his extensive expertise in technical operations and new product development to drive innovation in the field of in vitro diagnostics (IVD). With a strong focus on automated congenital immunoassay diagnostic products, Thomas manages critical technical and design transfer responsibilities that are essential for the successful launch of these complex diagnostic solutions. His role involves leading cross-functional teams to ensure that program goals are met efficiently, while also collaborating with third-party manufacturers (TPMs) to enhance product development processes.
Thomas’s proficiency in project management is complemented by his deep understanding of Good Manufacturing Practices (GMP) and regulatory compliance, particularly pertaining to U.S. Food and Drug Administration (FDA) standards. He is adept at navigating the intricacies of Verification and Validation (V&V) processes, which are crucial for ensuring the reliability and accuracy of diagnostic tests. His experience in Therapeutic and Immunosuppressive Drug Monitoring (TDMs) further enriches his contributions to the development of immunoassays that address critical healthcare needs.
In addition to his technical acumen, Thomas is skilled in implementing Corrective and Preventive Actions (CAPA) to enhance product quality and mitigate risks throughout the product lifecycle. His commitment to advancing diagnostic technologies not only supports Abbott's mission to improve patient outcomes but also positions him as a key player in the evolution of diagnostic testing in the healthcare industry. Through his leadership and innovative approach, Thomas Rosiere continues to make significant strides in the development of cutting-edge diagnostic solutions that have a lasting impact on global health.