Process Development Sr Principal Scientist
Core
Lead process development and lifecycle management for commercial drug product formulation and fill/finish processes across various modalities.
Role type
Senior Principal Scientist (Process Development)
Builds
Commercial biologic drug product presentations
Domain
Biopharmaceuticals / Biologics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process development, formulation design, lifecycle management, root cause analysis, continuous improvement, regulatory submissions, statistical analysis, aseptic processing, scale-up, technical transfers, SPC, DOE
Preferred skills
Pharmaceutics/Biotechnology/Engineering background, end-to-end development for liquid/lyophilized/oral solids, parenteral biologics expertise, protein stability knowledge, cGMP/ICH guidelines, equipment design, global manufacturing experience
Technologies
Advanced IS systems, statistical software
Responsibilities
Plan and execute laboratory studies for drug product design and process development; support fill/finish operations with troubleshooting and process capability analysis; drive continuous improvement via first principles; lead global cross-functional teams; author technical protocols and regulatory submissions; deliver progress reports to management.
Seniority
Principal, hands-on IC with leadership
