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Stephen Hawley
Biopharmaceutical Development Professional
Professional Background
Stephen Hawley is a highly accomplished professional in the biotech drug development industry, known for his extensive experience and expertise in CMC (chemistry, manufacturing, and controls) team development and leadership. With a strong focus on the development, characterization, technology transfer, and manufacturing oversight of expression and purification processes for protein therapeutics, Stephen has made significant contributions to the field. His comprehensive oversight of drug substance CMC activities spans from nonclinical development through to the process development phases necessary for the manufacture of Phase 3 clinical trial and commercial material.
As a Senior Principal Scientist at Ansun Biopharma, Inc., Stephen has played a crucial role in leading high-value development projects, demonstrating a proven record of strategic project management and successful execution. His ability to effectively communicate and collaborate with stakeholders has fostered productive relationships, making him a highly valued team member.
Previously, Stephen held several prominent positions at NexBio, Inc., where he advanced through the ranks from Assistant Director to Senior Director, Drug Substance Development. His progression illustrates not only his technical expertise but also his leadership skills, as he guided various teams in process development and CMC regulatory submissions. As Director of Process Development & Manufacturing, he spearheaded initiatives that led to the successful advancement of multiple projects within the company.
Education and Achievements
Stephen's academic journey laid the foundation for his successful career in biochemistry and biotech. He obtained his Ph.D. in Cellular Biochemistry from the prestigious University of California, Irvine, where he developed a strong understanding of cellular processes and biochemistry. Complementing his doctoral studies, Stephen conducted postdoctoral research at The Scripps Research Institute, further enhancing his expertise in research and development within the biopharmaceutical sector.
Throughout his career, Stephen has demonstrated excellence in writing and reviewing CMC regulatory submissions, contributing significantly to the advancement of biotechnology and therapeutic innovations. His ability to manage CMC activities and his proficiency in overseeing high-stakes drug substance development projects have introduced efficiencies and breakthroughs in the drug development pipeline.
Stephen’s knowledge and skill set are complemented by his excellent interpersonal and communication abilities. These skills are vital in building and maintaining relationships with stakeholders, whether they be colleagues, regulatory bodies, or other partners in the biotech ecosystem. His approach facilitates collaborative efforts that are essential for the success of drug development projects.
Achievements
With a commitment to excellence, Stephen Hawley continues to be a key player in the development and advancement of biopharmaceuticals. His track record reflects not only his technical skills but also his strategic vision in guiding projects from concept to clinical trial phases. His leadership in CMC team development has empowered many professionals in his field, enhancing their capabilities and fostering a culture of innovation.
Stephen's contributions to the biotech industry exemplify a dedication to improving human health through the development of effective therapeutic solutions. He remains at the forefront of the biotechnology sector, leveraging his vast expertise to confront the challenges inherent in drug development, making a tangible impact on patient care and treatment outcomes.