Experience

Treximo (A ProPharma Group Company)

• United States
• Business Consulting and Services
• 1 - 100 Employee

• Consultant

  • Sep 2017 - Present



JLPS Pharmaceutical Consulting, LLC

• Owner

  • Apr 2017 - Present



Aprecia Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• QC Manager

  • 2016 - Present



Validant

• United States
• Business Consulting and Services
• 100 - 200 Employee

• Pharmaceutical / Medical Device Consultant

  • 2012 - Present

  As part of the McNeil Consumer Healthcare Consent Decree, assisted client in determining stability data required to support distribution practices. Authored stability study protocols / reports, and reviewed data for observable trends. Wrote SOPs and Quality Risk Management (QRM) protocols / reports on the client’s new process. As part of the McNeil Consumer Healthcare Consent Decree, assisted client in determining stability data required to support distribution practices. Authored stability study protocols / reports, and reviewed data for observable trends. Wrote SOPs and Quality Risk Management (QRM) protocols / reports on the client’s new process.



Celgene

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Research Scientist II

  • 2008 - 2012

  Promoted from Associate Manager QC to oversee numerous method transfer activities in multiple labs globally for this biotechnology firm that manufactures drug therapies for cancer / inflammatory disorders. Revised SOP to remove extraneous testing, and authored first corporate work practice on analytical method transfers. Promoted from Associate Manager QC to oversee numerous method transfer activities in multiple labs globally for this biotechnology firm that manufactures drug therapies for cancer / inflammatory disorders. Revised SOP to remove extraneous testing, and authored first corporate work practice on analytical method transfers.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manager / Team Leader

  • 2002 - 2007

  Oversaw the Analytical Development Group supporting QC, analytical and manufacturing sites worldwide. Assisted in method troubleshooting, QC laboratory, & manufacturing investigations to determine root causes of OOS / OOT results. Developed & validated new analytical test methods for marketed pharmaceutical products including drugs such as Lipitor, Zyrtec, and Neurontin. Led ten analysts. Oversaw the Analytical Development Group supporting QC, analytical and manufacturing sites worldwide. Assisted in method troubleshooting, QC laboratory, & manufacturing investigations to determine root causes of OOS / OOT results. Developed & validated new analytical test methods for marketed pharmaceutical products including drugs such as Lipitor, Zyrtec, and Neurontin. Led ten analysts.



Bristol Myers Squibb

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Research Scientist

  • 1996 - 2002

  Managed team of seven analytical chemists supporting drug development for new chemical entities (NCEs) from early development through IND and NDA stages. Introduced Zymark MultiDose Automated Dissolution System to perform around the clock automated dissolution testing. Developed/ validated sensitive HPLC method for an API trace impurity to keep project on track. Earlier: Research Scientist, Bristol-Myers Squibb Company. Senior Scientist, Applied Analytical Industries. Associate Scientist, Warner-Lambert Company. Show less