Process Engineer, Technical Operations - Small Molecule Drug Substance
Core
Provide technical support for the design, commissioning, qualification, and ongoing commercial manufacture of active pharmaceutical ingredients (APIs) via chemical synthesis, purification, and crystallization.
Role type
Process Engineer, Technical Operations
Builds
Active pharmaceutical ingredients (APIs) for patients in the U.S.
Domain
Biopharmaceuticals / Small molecule manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Chemical Engineering, Chemical synthesis, Purification and isolation, Crystallization and drying, Process scale-up, Technology transfer, cGMP compliance, Deviation investigations, Root cause analysis, Data analysis
Preferred skills
Process development, Manufacturing operations, Lean Manufacturing, Continuous Process Improvement, Project Management
Technologies
cGMP, GMP, Lean Manufacturing
Responsibilities
Support capital project design, commissioning, and startup readiness; Execute technology transfers for new products and processes; Analyze process data to support performance monitoring and troubleshooting; Implement improvements in process robustness, product quality, and plant performance; Ensure compliance with cGMP, safety, and environmental standards; Partner with cross-functional teams for product introduction and lifecycle management
Seniority
Mid-level, hands-on IC
