Principal Engineer
Core
Lead end-to-end development, scale-up, technology transfer, and lifecycle management of synthetic and hybrid drug substance manufacturing processes.
Role type
Principal Chemical Engineer (Process Development)
Builds
Safe, robust, compliant, and manufacturable processes for synthetic and hybrid drug substances
Domain
Pharmaceutical manufacturing (synthetic/hybrid drug substances)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Chemical engineering fundamentals, reaction engineering, thermodynamics, kinetics, heat and mass transfer, mixing, hydrodynamics, separations, filtration, drying, solid-liquid handling, equipment design, resin selection, peptide synthesis, process modeling, statistical analysis, design of experiments, process safety, cGMP compliance, regulatory filing support
Preferred skills
Solid and liquid phase peptide synthesis, GMP transfer, CDMO oversight, facility and equipment fit assessment, process validation, data integrity, quality systems
Technologies
HPLC, LC-MS, GC, NMR, FTIR, LOD, TOC, FBRM, particle-size analysis, process analytical technologies
Responsibilities
Lead chemical engineering deliverables from early development through commercialization; Provide on-the-floor support and troubleshooting at CDMO sites; Lead process risk assessments and failure-mode evaluations; Manage technical risks and coordinate interdependent workstreams; Author and defend engineering reports and regulatory filing sections; Establish engineering standards and technical documentation workflows
Seniority
Principal, strategic leadership with hands-on technical execution
