Dallas-Fort Worth Metroplex
Strategic, results-driven manager offering expertise in developing vision and fully implementing innovative solutions that serve business and user needs across organizations. Excels in leading digital and pharma strategy, product development, and regulatory submissions. Resourceful business partner and project manager known for cultivating and maintaining positive, productive relationships in a matrixed environment. Leverages agile planning methodology that enables state-of-the-art and data-driven strategies such as Accelerated Predictive Stability (APS) to speed product development, while reducing costs, and increasing product knowledge or utilize AI / data science in co-development with MSFT that empower scientists. Collaborative leader and team contributor with expertise in coaching, directing, and mentoring diverse, cross-functional teams to execute with a high sense of priority / urgency. MBA (candidate), Ph.D., MS.
Led organizational transformation that optimized efficiency, planning, and delivering the products globally and ensured operational discipline and GxP / HSE adherence, moving the team to a trusted delivery partner with excellent KPI’s in delivery, data integrity, and quality. • Oversaw a team of analysts, a project leader, and compliance experts, 15 associates, who specialized in aseptic drug product development and GMP manufacturing support. • Drove the strategy and managed the budget of the team to adapt and evolve to better support the NVS portfolio. • Ensured and monitored team performance, robust resource planning, and operational excellence. Reduced overdue, delay and misses to zero improving all team KPI above monitoring level. • Supported site decommissioning, from instrument retirement, and transfer, to associate announcement and support. Finalizing exit three months ahead of schedule and within <80% of budget.
Developed and implemented predictive models and quality by design (QbD) approaches to understand in depth the chemical and physical basis of drug product degradation. Managed and mentored a team of analysts and scientists, organized regular scientific training sessions and presentations with eight direct reports. • Implement end-to-end Accelerated Stability Assessment Protocol (ASAP) and acted as SME. • Successfully delivered first phase I filling with only APS data, speeding the phase I development by ~3 months. • Monitored the Design Of Experiment (DOE) mixture design for excipient compatibility and formulation stability improvement, writing a new guideline. • Partnered with regulatory guidelines and authorities, wrote scientific reports and assessments that supported filings, and CSU in answering authorities’ questions regarding stability and excursion. • Project-managed stability study design followed up and reported for development and regulatory filling. • Operated under GMP regulation.
Dr. Konishi, NRC, Montreal ,Quebec • Monitored Homology modeling of Dopamine D2 / D4 receptors and QSAR study of lead antiangiogenic compounds and synthesis of lead compounds. Co-supervised a Ph.D., and master's students, and an analytical technician. • Developed LC-MS / MS methods and eye drop formulation using a Design of Experiment (DOE) study of excipients compatibility • Developed and implemented procedures and utilized a common database for protocols and scientific reports.
Prof. N. Moitessier and Prof. G. Just, McGill University, Quebec • Organic and computational Chemistry: Computer-aided design and synthesis of asymmetric catalysts for the reduction of pro-chiral ketones Development and characterization of novel stable ozonides (trioxolanes) as effective antimalaria drugs • Analytical Chemistry: Method development for chiral HPLC analysis and isolation, Characterisation using RMN, HPLC, Mass HR, mp, IR • Co-supervision of 4 undergraduate students and 2 Ph.D. students.
Prof. J. Eustache, Haute Alsace University, Mulhouse, France • Medicinal chemistry New approaches towards the treatment of mycobacterial infections: inhibition of arabinosyltransferase and of the biosynthesis of mycobactins • Analytical chemistry Method development for HPLC isolation and characterization (RMN 1D-2D, HPLC, Mass HR, mp, IR, elemental analysis)