Senior Scientist, Small Molecule Chemical Engineering
Core
Develop safe and robust manufacturing processes for late-stage small molecule projects through process characterization, technology transfer, and validation.
Role type
Senior Scientist, Small Molecule Chemical Engineering
Builds
Manufacturing processes and supply support for small molecule drug substance
Domain
Pharmaceutical manufacturing / Chemical Engineering
Required skills
Process characterization, Technology transfer, Validation, Quality Risk Management, Statistical design of experiments (DOE), cGMP compliance, Risk assessment, Deviation investigation, Good Documentation Practices (GDP), Laboratory experimentation, Kilo lab scale operations
Preferred skills
Unit operations (chemical reactions, work-up, crystallization), Regulatory file authoring, Process scale-up, Mathematical modeling, Quality by Design (QbD), Theoretical scaling calculations
Technologies
Bioreactors, Chromatographic techniques, Computational design tools
Responsibilities
Conduct hands-on experimentation at laboratory and kilo lab scales; Transfer technology to commercial manufacturing facilities; Participate in risk assessments and deviation investigations; Execute statistical design of experiments for process robustness.
Seniority
Senior, hands-on IC
