Executive Director, Purification Process Development – Pivotal & Commercial Biologics
Core
Leads late-stage purification and conjugation process development and characterization for biologics from pivotal through commercial launch, including post-launch lifecycle management.
Role type
Executive Director, Biologics Process Development
Builds
Robust purification and conjugation processes for clinical and commercial manufacturing of biologics
Domain
Biopharmaceuticals / Biologics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Purification process development, Conjugation processes, Chromatography (resin and membrane), Filtration unit operations, Viral clearance design, Control strategy deployment, Regulatory filing support (IND/BLA/MAA), cGMP compliance, Team building and mentoring, Budget management, Strategic planning
Preferred skills
Industry best practices knowledge, New process technology implementation, Due diligence for asset purchases, Cross-functional leadership, Scientific writing
Technologies
Chromatography systems, Filtration systems, Conjugation equipment
Responsibilities
Provide leadership to the Biologics Purification Process organization, Account for development and clinical tech transfer of purification processes, Support regulatory filings and agency interactions, Partner with cross-functional teams for commercialization, Drive implementation of new process technologies, Hire and develop team members, Manage department budget
Seniority
Executive, Strategic Leadership
