Director, Drug Substance and Early Development

Role Summary

Director, Drug Substance and Early Development overseeing early development activities for the clinical-stage biologics pipeline, including monoclonal antibodies and fusion proteins. Responsible for advancing drug substance development strategy, formulation, cell line development, bioreactor scale-up and tech transfer to ensure robust, scalable, and compliant processes for clinical and future manufacturing. Remote work option available for US-based candidates.

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.

Qualifications

• PhD in Biochemical Engineering, Cell Biology, Biotechnology, or related field with 10+ years of relevant industry experience; or MS 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.