Responsibilities of the Principal Scientist- Drug Substance Scale Up & Manufacturing:

• Help manage late-stage small molecule drug substance development and manufacturing activities at global CRO/CMO sites.
• Help ensure regulatory compliance at vendor sites.
• Serve as a subject matter expert for drug substance process development, manufacturing process scale-up, process technology transfers, process validation, and process characterization activities.
• Help identify and develop phase appropriate control strategies for raw material and drug substance manufacturing.
• Author, review and approve specifications, batch records and other critical documents as required.
• Work with other process chemists to support early-stage manufacturing process development/manufacturing and transfer the project to late-stage development.
• May require hands-on chemistry to develop proof of concept for novel chemistry, process optimization studies, process troubleshooting, process characterization studies, etc.

Requirements of the Principal Scientist- Drug Substance Scale Up & Manufacturing:

• Ph.D. in Organic Chemistry or Chemical Engineering with 5+ years, or equivalent, of relevant process development and manufacturing experience.
• Demonstrated ability in late-stage process development, validation, and commercial manufacturing at global CMOs in an accelerated environment is required.
• Previous experience with QbD tools including risk assessment, design of experiments and data analysis is a plus.
• Prior outsourcing experience working with external partners is highly desired.
• Analytical skills should include all modern spectroscopic techniques including: NMR experimentation and techniques; IR; mass spectroscopy, ReactIR and UV/Vis; separation techniques including chromatography: HPLC, GC, TLC, flash chromatography, chiral separations and derivatization; solid state characterization; gravimetric analysis and titration.