Director, Drug Substance and Early Development

As the Director of Drug Substance and Early Development, you will lead early development activities for our clinical-stage biologics pipeline, including monoclonal antibodies and fusion proteins. This role will be instrumental in advancing our drug substance development strategy, including formulation, cell line development, bioreactor scale-up and tech transfer, ensuring robust, scalable, and compliant processes to support clinical and future commercial manufacturing. Experience working with biologics and large molecules is required in order to be successful in this role. This is a high-impact, hands-on role at a growing biotech, ideal for a leader who is energized by building, driving cross-functional execution, and working closely with CDMOs and internal technical teams. Lead MSAT activities for monoclonal antibodies and fusion proteins, from early development through clinical manufacturing. Oversee cell line development, clone selection, and characterization in collaboration with internal teams and external partners. Design and optimize bioreactor processes (shake flask to pilot scale) to ensure scalability, robustness, and regulatory compliance. Drive formulation development strategies for early-phase programs, ensuring compatibility with downstream processing and stability requirements.