Michael Markey Email & Phone Number

Tokyo, Jp

• Lead for cross-functional CMC team including analytical, formulation and manufacturing• Drug substance process optimization, manufacturing, scale-up and IND-supporting activities• Vendor selection, CMO management and tech transfer • Write and review relevant sections of IND and other regulatory filings • Represent CMC to cross-functional teams including clinical, quality, regulatory, project management, finance and executive leadership• Long range planning for CMC budget and submission milestones

London, Greater London, Gb

Albany, Ny, Us

Team leader for the Albany site non-GMP kilo lab (up to 400 L). Supervised a team of 4-6 and coordinated the chemical manufacture for complex chemical entities on multi-kilogram scale which often supported early phase activities. In this position I would help transfer multi-step operations across sites and up in scale (from <100 mL up to >1000 L) through document preparation (batch records, BFD's, process safety assessments) or key discussions. In any given year I would oversee or be part of >25 projects which ran anywhere from impurity synthesis to proof of concept demonstration batches to manufacture of GMP starting material or NCSS API’s. • Lab head for the non-GMP kilo lab.• Supervised a team of 4-6.• Experience with jacketed 1-100 L reactors, 80 L stirred pressure filter, and 100/400 L Pfaudler fixed reactor train.• Synthesized non-GMP API’s, GMP starting material, and performed demonstration batches.• Oversaw technology transfer through development (<100 mL) into manufacturing facility (>1000 L).• Performed use-tests as a means of troubleshooting or helping to support GMP deviations/investigations.• Part of multi-site process safety discussion group.• Routinely prepared technical documents – weekly updates, final reports, batch records, BFD’s, deviations.• Compose and discuss performance reviews with direct reports.

Albany, Ny, Us

Member of the chemical development team focused on process understanding through experimentation. Developed practical and technical approaches to help navigate programs through multi-step transformations at the milligram up to multi-kilogram scale.• Optimized reaction conditions for scale-up.• Monitored reaction progress, product quality, and key metrics with various analytical techniques (NMR, HPLC, GC, LC/MS, KF, TLC, ROI, and TGA).• Performed process safety assessment with RC1, DSC, and TSU.• Synthesized target molecules, i.e. impurity markers, custom synthesis.• Experience with flow chemistry (Corning® Advanced-Flow™ Reactor).• Supported research and development through literature searches and SciFinder.

Ph.D., Organic Chemistry

Bs, Chemistry