Senior Director, Process Development

Role: Senior Director of Biologics Process Development, leading the development and optimization of complex biologics using CHO cell platforms within a biopharmaceutical setting. Responsibilities: oversee process development from early to late-stage; manage and mentor a team of Process Scientists and Engineers; ensure seamless tech transfer, process scalability, and cGMP compliance; collaborate cross-functionally with Research, Manufacturing, and Quality teams; drive innovation in upstream bioreactor processes, media optimization, and process tech advancements; oversee operational planning, resource allocation, and project delivery. Requirements: Ph.D. in Chemical Engineering, Bioengineering, Biochemistry, or related, with 10+ years industry experience (or M.S./B.S. with 14+ years), including 5+ years managing technical teams; deep expertise in CHO cell culture, biologics process development, cGMP manufacturing, and tech transfer; experience authoring or reviewing CMC sections for regulatory filings. Preferred: experience with biotherapeutics (bispecifics, fusion proteins, glycosylated proteins), process characterization, and validation, along with knowledge of regulatory guidelines for IND filings. HighValue: biologics, complex biologics, CHO cell culture, process development, cGMP, tech transfer, biopharma R&D and manufacturing, biologics pipeline stages. WorkSetup: not specified.