Developed Stage Gate Drug System at Manufacturing Science and Technology Group for late-stage development and commercial manufacturing for the treatment of rare diseases
Developed and implemented a business process and technical frameworks with selection criteria for the selection and management of CDMOs in the USA, EU, India and China for small molecules, biologics, viral vectors and cell-therapy products API and DP.
Developed framework and KPIs for Portfolio Management and Strategic Planning in Commercial Technical Operations for the projection of annual budget
Developed project planning for the transfer of two vaccines from early clinical phase (I/II) to phase III and commercial launch (confidential mid-size bio/pharmaceutical client
Project Management for Phase I & II and Manufacturing programs, as well as process transfer to large pharma company for Phase III and commercial manufacturing
Audits of CDMOs in the USA, EU, India and China
Small molecule DS/DP CDMO for Phase 1&2 clinical trials in the EU
Small molecule API synthesis and DP for Phase 1&2 clinical trials in the EU
Biologics DS and DP CDMO for Phase 2 clinical trials in the EU
Small molecule API synthesis for Phase 1 clinical trials in the EU
Small molecule API synthesis for Phase 1 clinical trials in the EU
Small molecule API synthesis for Phase 1 clinical trials in the EU
Small molecule API synthesis for Phase 1 clinical trials in the EU
Fill-&-Finish facility for sterile drug product manufacturing
Fill-&-Finish facility for sterile drug product manufacturing
Fill-&-Finish facility for sterile drug product manufacturing
Protein nano-particle API manufacturing for Phase 1 clinical trials
Protein nano-particle API manufacturing for Phase 1 clinical trials
QMS for early-stage bio/pharmaceutical companies
CRO Start-up with the full range capabilitues to support bio/pharmaceutical project
Company has successfully manufactured and released DS/DP, filed IND and started Phase 1 clinical trials
Company has successfully manufactured and released DS/DP, filed IND and started Phase 1 clinical trials
In-progress
Company has successfully filed IMPD for the Phase 1 clinical trials in the EU
Budget for R&D and Clinical Programs
Lead projects on long-range planning, forecasting, and reporting.
Developed and led the annual budgeting and quarterly forecasting processes, providing insightful analysis and recommendations to senior leadership. Managed financial reporting, including a monthly comparison of actual vs. budget results and relevant variance analysis to enable organization to deliver on key objectives. Performed trend analysis and scenario modeling to evaluate performance and identify opportunities.
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Key Pharma
Carlsbad, California, United States
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