As the Development Director at Aptimmune Biologics Inc., Steve Berger plays a pivotal role in advancing the company's mission to develop innovative mucosal vaccines targeting PRRS (Porcine Reproductive and Respiratory Syndrome) and influenza virus in swine. With extensive experience in biotechnology and biopharmaceuticals, Steve leads...
As the Development Director at Aptimmune Biologics Inc., Steve Berger plays a pivotal role in advancing the company's mission to develop innovative mucosal vaccines targeting PRRS (Porcine Reproductive and Respiratory Syndrome) and influenza virus in swine. With extensive experience in biotechnology and biopharmaceuticals, Steve leads a dynamic team of professionals, overseeing both multi-site and multi-product vaccine manufacturing operations. His leadership encompasses a diverse group of up to 8 direct reports and 215 indirect colleagues, ensuring that all teams are aligned and focused on achieving strategic objectives.
Steve's expertise in technical project leadership is crucial as he navigates the complexities of technology transfer and clinical development. He is responsible for defining plant financial and performance metrics, closely monitoring results, and organizing cross-functional teams to address any operational gaps. This proactive approach not only enhances productivity but also ensures that the company meets its regulatory obligations, including compliance with USDA 9CFR, EU-GMP, OSHA, and environmental standards.
Under Steve's guidance, Aptimmune is poised to transition the groundbreaking research of Dr. Frederico Zuckermann into commercially viable products. His commitment to fostering a culture of continuous improvement is evident through his application of Six Sigma methodologies and the establishment of robust Standard Operating Procedures (SOPs). By leveraging his skills in regulatory affairs and validation, Steve ensures that Aptimmune remains at the forefront of the biotechnology industry, ultimately contributing to the health and productivity of the swine population and the agricultural economy at large.
