With 20+ years of experience spanning Project Management leadership, Product Development & Process Improvement efforts, I have been instrumental to pharmaceutical & drug development by building and managing partnerships while also focusing on implementing process improvements, ultimately influencing portfolio/pipeline and revenue growth. It is my passion to execute alliance management strategies, enable product delivery optimization, & accelerate performance efforts to ensure project & program success. As a leader, I am well versed in cross-functional (cross-cultural) team management, regulatory compliance, & in-depth professional collaboration.Key Achievements Include: ✅ Oversaw drafting and submittal of 2 NDAs and 18 ANDAs over 7 years to drive new drug development opportunities, launching 15 commercial products and influencing sales and revenue generation for the company✅ Established a $3.5M world-class small-scale Pilot Plant with facility system upgrades, including security cameras, burglar alarms, access control keypads, and a raw material vault, coordinating with the DEA to inspect, release, declare cGMP, and approve licensure for the Pilot Plant, achieving a Class 1000 certification in 2013✅ Served as the face of the company by interacting with customers while managing internal Project Management teams and external client teams to create a project strategy and deliver account requirements, successfully deploying new pharmaceuticals into the market✅ Instrumental to the IND/NDA filings and development initiatives for an oncology program, influencing a $140B market capitalization for a Pharmaceutical company✅ Formulated cost justifications for $500K in capital equipment acquisitions, enabling accelerations in operational efficiency by 25%+Contact me through this profile if you wish to connect.
Listed skills include Validation, Pharmaceutical Industry, Technology Transfer, Cross Functional Team Leadership, and 19 others.
