Job ID: #9374
Principal Scientist- Drug Scale Up and Manufacturing
Research & Development
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.
Commonwealth Sciences is a professional recruiting firm specializing in Life Science, Medical Device, and Engineering Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.