Steve Hubert serves as the Senior Director of Manufacturing at Theriva Biologics, Inc., where he leverages his extensive expertise in biologics process development and manufacturing to drive innovative therapeutic solutions. With a strong focus on contract manufacturing management, Steve is instrumental in identifying and establishing...
Steve Hubert serves as the Senior Director of Manufacturing at Theriva Biologics, Inc., where he leverages his extensive expertise in biologics process development and manufacturing to drive innovative therapeutic solutions. With a strong focus on contract manufacturing management, Steve is instrumental in identifying and establishing strategic partnerships with contract manufacturing organizations (CMOs) to align with Theriva's ambitious manufacturing goals. His role encompasses overseeing the transfer of complex manufacturing processes, utilizing his deep knowledge in expression systems, microbial fermentation, and large-scale mammalian cell culture.
Currently, Steve is leading several key projects, including the development of a groundbreaking biologic delivered in a novel oral dosage form. This initiative not only showcases his proficiency in monoclonal antibody (mAb) production but also highlights his commitment to advancing recombinant therapeutics and vaccines. His expertise in purification and fill/finish processes ensures that products meet stringent cGMP standards, facilitating smooth transitions from clinical manufacturing to commercial readiness.
Steve's background in fermentation and bioreactor operations, coupled with his strong understanding of quality systems and regulatory compliance, positions him as a vital asset in the biopharmaceutical landscape. His collaborative approach to product development and R&D fosters a culture of innovation at Theriva, enabling the company to navigate the complexities of the life sciences industry effectively. As he continues to drive forward-thinking projects, Steve remains dedicated to enhancing therapeutic options that can significantly improve patient outcomes.