Director, Bioprocess / Process Development – Pivotal Drug Substance

Role: Director of Bioprocess / Process Development leading cell culture and purification for late-stage biologics, including monoclonal antibodies, bispecifics, and biosimilars, to support Phase II/III and commercial drug substance manufacturing. Responsibilities: oversee a multi-site team of 30+ scientists and engineers, advancing integrated processes through development, characterization, lifecycle management, and process transfer; collaborate with engineering, manufacturing, and external partners; author and review regulatory submissions, and promote innovative bioprocess technologies. Requirements: PhD in relevant fields or equivalent experience (10+ years in biopharma process development), with at least 4 years of managerial experience, strong expertise in cell culture or downstream purification, and familiarity with late-stage biologics, process validation, and regulatory interactions. Preferred: deep experience in biologics process development, scientific leadership, publications/patents, and active engagement in the scientific community. High-Value: biologics (mAbs, bispecifics, biosimilars), late-stage development (Phase II/III, regulatory filings), cross-functional leadership, and multi-site process development. Location: Cambridge, MA and/or Thousand Oaks, CA, with expected leadership of large teams and strategic initiatives.