Boston Analytical Apr 2010 - Apr 2013
Microbiology Manager
Hyaluron, Inc - Burlington, MA Feb 2007 - Mar 2010
QC Microbiology Manager
Toxikon Corporation - Bedford, MA 2000 - 2007
In-Vitro Laboratory Manager
Education:
Regis College 1994 - 1998
Bachelor of Arts (B.A.), Biology/Biological Sciences, General
Skills:
Gmp Fda Validation Quality System Glp Quality Control Microbiology Quality Assurance Pharmaceutical Industry Sop Biopharmaceuticals Lims Biotechnology Laboratory Aseptic Technique Usp Capa Gxp Cleaning Validation Regulatory Requirements Medical Devices Aseptic Processing Change Control Iso Sterilization Cgmp Practices Environmental Monitoring Pharmaceutics Lifesciences Bioburden 21 Cfr Part 11 Technology Transfer Cro Quality Auditing Management U.s. Food and Drug Administration Software Documentation Filtration Drug Discovery Lyophilization Sterility Assurance Endotoxin Laboratory Information Management System Vaccines Biocompatibility Iso 13485 Iso 17025 Sop Development Laboratory Skills
Thermo Fisher Scientific Tewksbury, MA Jun 2013 to Jul 2014 ISO 17025 Lead ConsultantBoston Analytical, Inc Salem, NH Mar 2010 to Apr 2013 Laboratory Manager, MicrobiologyHyaluron, Inc Burlington, MA Feb 2007 to Mar 2010 Quality Control Senior Supervisor, MicrobiologyToxikon Corporation Bedford, MA Aug 2000 to Feb 2007 A well-established contract research (CRO) companyToxikon Corporation
2002 to 2007 Lab Manager & Study DirectorToxikon Corporation
2001 to 2002 Lab SupervisorToxikon Corporation Bedford, MA 2000 to 2001 Study Coordinator / Lab TechnicianMassachusetts General Hospital Boston, MA Aug 1998 to Aug 2000 Lab Technician
Education:
Regis College Weston, MA 1998 Bachelors in Biology