Philip Bauer

About Philip Bauer

I have enjoyed 32 years in small molecule drug development and CMC management. I have managed drug development for both drug substance and drug product through use of CMOs and CROs for CMC development activities for the last 18 years in small Pharma Biotech.My goal is to add value and quality to ensure team and corporate success that enables cost efficient CMC drug development.Specialities: Management of CMC Drug Development,Management of Drug Substance and Drug Product Manufacture,CMC project planning,Manage stability and analytical supporting CMC,Reviewed and prepared Development reports for API and Drug Product,Managed API physical characterisation through salt screens and polymorph screens,Managed development of controlled crystallisation for API ControlsManage development activities from preclinical to Phase 4,Preparation of CMC submissions for US & EU filings,Managed IND CMC from initial IND until NDA submission,Budget planning for CMC,Management of CRO\'s & CMO\'sPrepare Due Diligence CMC DocumentsSupport Due Diligence Activities

Experience

1. VP of Chemistry, Manufacture and Control

   Salarius Pharmaceuticals

   Mar 2020 — Present · Houston, TX, US

   Oversight of Drug Substance and Drug Product Development Activities and CMO Manufacture. Define and manage Development and budget supporting CMC and its impact on Clinical Development.

Education

• Southern Illinois University Edwardsville

  BS, Chemistry

  1976 — 1981

• University of Wyoming

  PhD, Organic Chemistry

  1981 — 1985

• University of Notre Dame

  Post Doc, Chemistry

  1985 — 1986