Director of Drug Substance Development

A company is looking for a Director of Drug Substance and Early Development.

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 to ensure scalability, robustness, and regulatory compliance

Required Qualifications

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

Hands-on experience with monoclonal antibodies and / or Fc fusion proteins

Strong understanding of formulation development for early-phase biologics

Experience working with CDMOs and managing outsourced development / manufacturing activities