Summary:
The Scientist of Analytical Development will be working on drug substance candidates across all stages of development. They will also be working cross functionally with CMC related teams to perform analysis for process improvement.
Description:
- Analyze in-progress, toxicological, finished drug substance, and drug product samples routinely or atypically (i.e. release and stability testing)
- Manage new and ongoing development projects
- Write scientific papers and parts of the regulatory filings' Chemistry, Manufacturing, and Controls (CMC) section.
- Develop and/or optimize analytical methods
- Revise SOPs as needed (e.g. Analytical Methods, Equipment Procedures, Material Specifications)
Requirements:
- BS/MS/Ph.D. Degree in Chemistry or related field
- Practical knowledge of HPLC, MS, and GC
- Comfortable with the operation and troubleshooting of instrumentation (lab equipment)
- Experience following SOPs (i.e. Analytical Methods, Equipment Procedures, Material Specifications)
- Understanding of Regulatory filing and GMP protocols
