Key member of executive team that transitioned URL from generic to brand pharmaceuticals. Company needed to reorganize and implement state of the art, premier quality systems to become a specialty pharmaceutical company.Part of the Team to turn the company into an attractive acquisition for sale to Takeda USA.
Sourced and built redundant supply chain for company’s number one Brand, Colcrys®. Traveled internationally and negotiated global supply agreements to ensure consistent and steady supply chain including back up plans in the event of natural disasters.
Instrumental in acquiring FluidAir Pharm Pro. URL Pharma lacked appropriate development and commercial scale capabilities for fluid-bed manufacturing. Led advance team in acquisition of facility (US$8M deal) and oversaw integration. Implemented a program for multi-site production and critical commercial business redundancy achieving site approved for commercial production of Colcrys®.
Sped up launch and scale-up time for new products. Developed a team approach to product transfer and product improvement at URL Pharma. Implemented metrics to create transparency, accountability and improve work standards and operational excellence via the chemistry and manufacturing services department (CMS). Extracted non-core competencies from R&D, production and laboratories to develop team approach to product transfer and product improvement.
Enhanced quality / reduced costs by US$1.7M with continuous process improvements.
Transformed the technology transfer process to achieve robust and repeatable results. Created the team of chemistry and manufacturing services (CMS) and pharmaceutical process engineering (PPE) to capture and record the institutional knowledge of products and processes. CMS and PPE performed long-term statistical analysis to evaluate product improvement opportunities ensuring a continuum between R&D and commercial operations.
Created a Pharmaceutical Process Engineering (PPE) Program. As part of the CMS program, process engineering was implemented to capture institutional process knowledge and monitor the ongoing performance of manufacturing products and processes.
Initiated new Environmental Health and Safety program. Hired the subject matter expert and implemented an enhanced program to raise awareness and compliance levels with local, state and federal programs.
Revolutionized the Quality Systems of URL Pharma. The company was struggling with quality issues including multiple recalls and multiple product discontinuations. Modernized cGMPs (Good Manufacturing Practices) and implemented state of the art quality practices and electronic systems. Received 24 FDA approvals and led 15 of those to launch.
Achieved first “no 483 inspection” result ever for company, andfollowed-up with seven consecutive “no 483 inspections”.
Developed and implemented the company’s first employee awareness program called “Quality First – Always.”
Lead Analytical R&D Scientist of the CMC and packaging of Sulfamylon®, a unique drug product used in the treatment of serious burns sterilized by gamma-irradiation.
Lead Analytical R&D Scientist of the formulation, CMC, packaging and delivery device of Apokyn®, a sterile injectable drug product used in the treatment of Parkinson’s Freeze. The product utilized a cartridge vial and pen injector. Collaborated with domestic and international contract manufacturers to ensure high quality, efficient production with appropriate costs.
Received four patents for the development, improvement of stability and uniformity for Mylan’s premier generic formulation of levothyroxine sodium tablets enabling Mylan to enter into one of the largest prescription drug markets in the Unites States.