Expertise:   

Led development and launch of numerous (40 plus) generic and proprietary injectable drug products for US, EU and Canadian markets. Proven knowledge of formulation development, process development, scale up, technology transfer and process validation.  Resolution of manufacturing and process validation issues. 

Worked extensively with client pharma companies (B2B) in developing and manufacturing proprietary drugs, including development proposals and strategies, monitoring studies, regulatory submissions, and product launches. Built client collaborations with face-to-face meetings and during batch productions at manufacturing plants.

Experience:  

Directed process development and technology transfer department for over 25 years at Baxter Healthcare Corp. as Senior Director/Director and Principal Scientist and also directed API Sourcing function. Headed formulation development, and compounding stability functions for over 10 years.

Other:   

Founding member of the Validation Discussion Group. Member, Parenteral Drug Association.