Head of Downstream BioProcess Development
Core
Lead the Biotherapeutics Downstream Process Development function, directing a multidisciplinary team to develop and characterize purification processes for biotherapeutics across early- and late-stage assets.
Role type
Senior IC Head of Downstream BioProcess Development
Builds
Purification processes for monoclonal antibodies, fusion proteins, and related biologic modalities
Domain
Biopharmaceuticals / Biotherapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Downstream purification platform technologies (chromatography, filtration), process characterization, viral clearance strategy, CMC regulatory submissions, technology transfer, scale-up, team leadership, cross-functional collaboration, external partner management, risk-based decision making, Good Manufacturing Practices (GMP), AI-enabled tools for experiment planning and data analysis
Preferred skills
Doctoral degree, advanced degree in biochemical/chemical engineering, biochemistry, or chemistry, experience with automation and digital tools
Technologies
Chromatography, filtration, AI-enabled tools, automation, digital tools
Responsibilities
Lead and develop a multidisciplinary team for purification process development; Serve on the biotherapeutics process development leadership team to set technical strategy; Work closely with upstream, analytical, and drug product development organizations; Oversee downstream development activities internally and at contract development and manufacturing organizations; Manage preparation, review, and approval of CMC sections for global regulatory submissions; Drive rapid, phase-appropriate development to Investigational New Drug applications; Lead technology transfer, scale-up, process characterization, and validation efforts; Mentor and develop leaders and scientists within the team
Seniority
Senior, strategic leadership overseeing multiple functional areas
