- Expertise in the development of cGMP fill and finish operations for pre-filled syringes and auto-injector systems including the development of comprehensive Chemistry and Manufacturing Control (CMC) sections of a New Drug Application (NDA)
- Experience in the identification and qualification of suppliers of device components and assemblies, drug solution excipients and active pharmaceutical ingredients (API)
- Experience in working with container closure system manufacturers in the selection of drug contact materials least likely to affect the long term shelf life of a given drug product
- Expertise in the design, conduct, and analysis of ICH compliant drug stability studies
- Experience in the development of or transfer of assay methods and specifications for API, excipients, and final drug product solutions