Director, Drug Substance and Early Development

About Us

About the Role

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. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely (US based).

Key Responsibilities

• 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.
• Collaborate cross-functionally with Analytical Development, Downstream Process Development, Quality, Regulatory, and Clinical Supply teams.
• Serve as a technical SME during tech transfer to CDMOs and during regulatory interactions.
• Author and review CMC sections of regulatory filings (IND/IMPD/BLA).
• Evaluate and implement new technologies to enhance upstream development capabilities.

Experience

• PhD. in Biochemical Engineering, Cell Biology, Biotechnology, or related field with 10+ years of relevant industry experience; or M.S. with 12+ years.
• Proven track record in upstream process development, cell line development, and bioreactor scale-up for biologics is highly preferred.
• Hands-on experience with monoclonal antibodies and/or Fc fusion proteins is required.
• Strong understanding of formulation development for early-phase biologics.
• Experience working with CDMOs and managing outsourced development/manufacturing activities.
• Familiarity with regulatory requirements for early- and late-stage biologics development.
• Excellent leadership, communication, and project management skills.