Director - Process Development, Downstream & Upstream
Core
Lead Process Development teams to advance biologics process development from early-phase programs through commercial readiness, ensuring successful transfer into manufacturing.
Role type
Director, Process Development (Upstream & Downstream)
Builds
Scalable upstream and downstream processes for biologics, including mammalian cell line engineering and drug substance biomanufacturing.
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
biologics process development, manufacturing lifecycle support, leadership, cross-functional collaboration, strategic planning, process transfer, facility fit assessment, process optimization, continuous improvement, talent development, customer-facing technical discussions, single-use bioreactor environment management
Preferred skills
multi-site strategic initiatives, mammalian cell culture, upstream process development, downstream process development, process characterization, technology transfer, commercial manufacturing readiness, stakeholder management, executive influence, process optimization, coaching and mentoring
Technologies
GPEx, GPEx Lightning, single-use bioreactor systems
Responsibilities
Lead Process Development teams and manage 2–10 direct reports; Define and execute department strategy based on scientific and business priorities; Oversee development of scalable expression, purification, and product quality processes; Support manufacturing through process transfer, technology transfer, investigations, and facility fit assessments; Partner with clients, project management, and leadership to meet timelines and expectations; Lead cross-functional and multi-site strategic initiatives and process improvement efforts
Seniority
Director, people leadership across multiple functions and sites
