David Semin is an accomplished Executive Director of Process Development at Amgen, where he leverages his extensive experience in the biotechnology industry to drive innovation and efficiency in drug development. With a robust background that spans from research to process development (PD), David is adept...
David Semin is an accomplished Executive Director of Process Development at Amgen, where he leverages his extensive experience in the biotechnology industry to drive innovation and efficiency in drug development. With a robust background that spans from research to process development (PD), David is adept at leading cross-functional teams focused on critical quality attributes (CQAs) across various modalities. His leadership in the Commercial Attributes Sciences department is pivotal, as he collaborates closely with Amgen’s Quality Control (QC) teams and external analytical testing networks to ensure the seamless transfer of analytical methods essential for Good Manufacturing Practice (GMP) production.
Under David's guidance, the Forensics, Product Contact Attributes, and Cleaning Characterization Attribute Sciences teams have become vital resources across Amgen, enhancing the company's capability to address complex process development challenges. His strong investigational skills in forensics enable him to dissect and resolve intricate issues that arise during product development, ensuring that processes not only meet regulatory standards but also align with Amgen's commitment to delivering high-quality biopharmaceuticals.
David's expertise in analytical chemistry, combined with his proficiency in techniques such as High-Performance Liquid Chromatography (HPLC) and spectroscopy, positions him as a leader in the field. His strategic vision and ability to foster collaboration across departments are instrumental in advancing Amgen's mission to innovate in the pharmaceutical industry. As he continues to spearhead key projects, David remains dedicated to enhancing the efficiency and reliability of drug development processes, ultimately contributing to the successful delivery of life-changing therapies to patients worldwide.
