• Support the development and execution of CMC Regulatory strategies for and in conjunction with client organizations.• Responsible for the generation of new and ongoing CMC Regulatory activities as they pertain to INDs, CTAs, and commercial marketing applications.

• Strategic CMC lead for Vertex’s ATR inhibitor program (VX-970 and VX-803) and Cystic Fibrosis second generation program (pre-clinical). • Managed a cross functional team in the generation of CMC drug product eCTD sections for NDA and MAA filings for a pediatric program in Cystic Fibrosis. • Acted as CMC lead for Vertex’s commercial (Incivek) and development (VX-135) Hepatitis C portfolio. Responsibilities consisted of post-marketing changes/requirements as well as global CMC development activities.• Acted as lead for two substantial CMC amendments in Vertex’s Rheumatoid Arthritis program.• Participated in the preparation and submission of multiple Type C FDA meeting requests.• Managed Vertex US and Puerto Rico State License compliance requirements.

• Acted as lead in the CMC response effort in support of Kalydeco approval in Australia. • Responsible for coordinating post-approval changes to the drug product sections of the NDA and NDS for Incivek for Hepatitis C.• Managed Vertex state license compliance requirements.

• Responsible for analytical development activities related to Saridegib Drug Product formulation development as well as the development of the third generation API synthetic pathway.

● Responsible for addressing Feraheme analytical CMC questions from the European Medicines Agency in support of EU marketing approval.● Coordinated and oversaw the development, validation and implementation of new analytical methods, in support of the continuous quality improvement of CMC processes as they relate to Feraheme and in response to a Form 483 from the FDA. This included the coordination of regulatory changes.● Responsible for the implementation of 18 Feraheme Drug Product (DP) analytical and microbiological methods at European Quality Provider, including initiation and management of technical relationship.● Coordinated and completed method transfer activities of Feraheme DP to China in support of Chinese clinical trial activities. Included onsite training.

● Lead analytical scientist responsible for analytical testing and remediation activities in preparation for post approval inspection.● Oversaw the development, validation, and regulatory implementation of new analytical methods and technologies internally and at second source manufacturing sites around the US.● Independently made decisions that impact and improve the routine operation of internal and external Quality Control department operations.● Authored two successfully audited Standard Operating Procedures pertaining to the validation and transfer of analytical methods based on ICH and good scientific practice.

● Responsible for late phase method development, validation and implementation at global manufacturing and contract testing sites.● Worked to identify and remediate analytical methods gap assessment pursuant to Phase III activities.

● Developed and validated Phase III ready analytical methods to be used for release testing of API’s, synthetic intermediates, and key starting materials.