Senior Director Of Analytical Science And Technology
CurrentLead the analytical strategy, development and optimization to drive and integrate innovative plans in alignment with evolving cross-functional and project team goals. Execute the management of the in-house analytical lab, strategic vendor partners, technical and operational from contract negotiation to management activities in collaboration with external CROs and CMOs ensuring high standards, compliance and operations under regulatory and voluntary cGMP requirements for Pharmaceutical characterization and development. • Built the analytical/bioanalytical lab from inception to voluntary cGMP level of compliance accommodating multifactorial dysregulated metabolism research, product development and quality control. Execution resulted in exceeding metrics that facilitated multiple Certificate of Analysis for multiple products that allowed for moving ahead with three clinical safety trials. • Drove the development of a bioanalytical multiplexing assay that was validated at two CROs sites that met a key strategic goal. Allowed for simultaneous targeting of 20 analytes in a single clinical trial sample achieving a reduction in time and cost estimated at $500K for PK analyses for two critical clinical programs.• Developed novel mechanism-based LCMS assay and cGMP-compliant assays resulted in simultaneously meeting both business development and product development goals. CMC Project Management and Resource Optimization/Allocation to support clinical and non-clinical collaborations resulted in meeting aggressive time-sensitive R&D goals.• Experimentally uncovered a novel chemical degradation mechanism of active ingredients in solid phase. Successful risk and mitigation planning resulted in the continuation of a critical clinical program. This Novel chemistry formed the basis of a deeper collaboration and achieved a prototype showing a reduced degradation rate of the active ingredients saving substantial time and cost reductions.
