Bio

Experienced Analytical and formulation Development scientist with Regulatory Affairs certification. Expertise in filing enabling activities including assay development/qualification/validation, laboratory investigations, and formulation development and troubleshooting for multiple dosage forms. Expert in the establishment of comparability and biosimilarity. Experience with writing and editing of CMC sections for multiple regulatory filings both in the US and the EU. Experience with elevating projects from clinical to commercial stage. Ability to successfully interact with team members throughout the US, EU, and Asia. Expertise at performing due diligence for in-licensing of early and late stage programs, CMO selection, etc.