Michael Casner

Background

About Michael Casner

I have been consistently successful in pharmaceutical product development, production and commercialization, from concept and product design through pilot manufacturing and deliverables. I strengthened product development and production, maintained high productivity levels, and ensured compliance with rigorous regulatory standards. Having identified innovative methods for drug development, synthesis and production that avoided infringement on existing patents, I am skilled in patent problem resolution. I have led the kinds of quality and cost management initiatives critical to resolving the growing challenges of the expanding globalization of pharma supply chains. I solved environmental, safety, throughput, yield, capital investment, impurities, and manufacturing troubleshooting, regulatory, and materials cost issues. In addition, I designed, developed, and demonstrated chemical processes from lab to manufacturing plant. I have been engaged in proactive process design, QbD. I evaluated patents and literature to determine FTO. Lead and coordinated project planning and implementation with business, analytical chemistry, process chemistry research, engineering, legal, regulatory, and manufacturing groups. I am a chemistry professional with industrial and academic experience in process synthetic organic chemistry, bio-organic medicinal synthetic chemistry, technology planning, and technology assessment. Specialties: process synthetic organic chemistry GMP manufacturing regulatory filings, including DMF, IND, aNDA and NDA Lean Sigma, Operation Excellence (OE), CMC, CAPA, Root Cause Analysis Develop and use analytical methods for process research: HPLC, NMR, GC, UV, TLC, IR, MS Crystallization methods and polymorphs (XRD). Hazards Analysis Proactive process design, QbD Homogeneous and Heterogeneous Catalysis Intellectual Property Trainer/Educator Nucleosides Peptides and peptide conjugates opiates amphetamines gold chemistry chiral resolution