Fda
Investigator and Safety Officer
Fda Jun 2013 - Aug 2014
Cmc Reviewer
Patheon 2010 - 2012
Senior Manager, Technical Services
Avrio Biopharmaceuticals 2009 - 2010
Director, Technical Services and Project Management
Watson Pharmaceuticals 1999 - 2009
Senior Manager Technical Services
Education:
Colorado State University;B.s., Chemical Engineering;;
Bachelors, Bachelor of Science, Chemical Engineering
Colorado State University
Bachelors, Bachelor of Science, Chemical Engineering
Skills:
Technology Transfer Gmp Validation Fda Manufacturing Process Optimization Regulatory Submissions Lean Manufacturing Budgets Strategy Portfolio Management Dea Capa Pharmaceutics Pharmaceutical Industry Gxp Formulation Biotechnology V&V Regulatory Affairs Quality Assurance Sop Change Control Quality System Glp 21 Cfr Part 11 Analytical Chemistry Aseptic Processing R&D Drug Development Computer System Validation Lims Regulatory Requirements Generic Programming Hplc Cleaning Validation Chromatography Clinical Development Cro Process Simulation Ind