Senior Process Engineer, Technical Operations - Small Molecule Drug Substance
Core
Provide technical leadership and process ownership for API manufacturing, supporting facility design, commissioning, technology transfer, and commercial production of small molecule drug substances.
Role type
Senior 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 synthesis, Purification and isolation, Crystallization and drying operations, Process scale-up, Technology transfer, Validation (pre-PPQ, PPQ), cGMP compliance, Troubleshooting, Process optimization, Root Cause Analysis (RCA), Data interpretation
Preferred skills
Capital project design, Batch documentation development, Continuous improvement initiatives, Cross-functional collaboration, Regulatory inspection readiness
Technologies
cGMP, RCA, PPQ
Responsibilities
Lead technical input to Capital Project Team for design reviews and startup readiness, Execute technology transfers for new products and processes, Drive process fit assessments and scale-up strategies, Analyze process data to drive performance improvements, Resolve complex technical issues during manufacturing campaigns, Ensure compliance with cGMP, safety, and environmental standards
Seniority
Senior, hands-on IC
