Sr. Engineer, Process Development
Core
Lead process development, technology transfer, and scale-up for synthetic and hybrid bioprocesses to support drug manufacturing.
Role type
Senior Process Development Engineer (Synthetic/Chemical)
Builds
Robust synthetic and hybrid processes for drug substances
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process modeling & simulation, reaction kinetics, mass transfer, separations, distillations, isolations, drying, hydrodynamic operations, technology transfer, risk assessment, regulatory documentation (CMC Module 3, RTQs), design of experiments, statistical analysis, lab and plant operations, cGMP compliance
Preferred skills
Bioprocessing unit operations for ADCs/oligonucleotides, first-principles modeling, analytical techniques (HPLC, GC, MS, NMR, FTIR), data science, HPAPI processing, linker payload chemistry
Technologies
HPLC, GC, MS, NMR, FTIR, FBRM, modeling platforms
Responsibilities
Author technical reports and regulatory documents, lead risk assessments, execute bench and kilogram-scale experimentation, design and optimize process models, support technology transfer and scale-up, monitor manufacturing processes, provide on-the-floor troubleshooting, collaborate with chemists and scientists
Seniority
Senior, hands-on IC
