Experience

Gritstone bio

• United States
• Biotechnology Research
• 100 - 200 Employee

• CMC Project Manager, Consultant

  • Feb 2021 - May 2021

  Pleasanton, California, United States



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manager, Consultant

  • Jun 2014 - Feb 2021

  Bridgewater, NJ Currently at Sanofi, Regulatory - External Manufacture North America. Working on Medical Devices, NDA's, MAA's, Post Approval CMC Submissions.



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs CMC Associate III

  • Jun 2012 - Jun 2014

  Joule contractor developing regulatory strategies for manufacturing/packaging/testing site changes, process changes, analytical method revisions, and primary packaging changes. Prepare PAS and CBE-30 submissions for US; Type IA, Type IB and Type II for EU and ROW; annual reports for Canada.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• CMC Strategist, Global CMC - Consultant

  • 2011 - 2012

  Critically evaluate manufacturing change controls for registrational impact and prepare Modules 2 and 3 in the Common Technical Document format for the CMC sections of Marketing Authorizations for new product submissions and preparation of variations.



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory CMC Manager

  • 2006 - 2010

  Produced high-quality and time-driven documents for multiple NDA and MAA’s submissions, IND/IMPD’s, various CBE’s, Prior Approval Supplements and amendments to Health Authorities on a world-wide basis.



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Fellow/Principal Scientist

  • 1997 - 2005

  Served as the subject matter expert for projects and technologies within a variety of standard and novel dosage forms including combination products, biologics, melt extrusion, transdermals and novel excipients.



Ciba Pharmaceuticals

• Research Scientist

  • 1986 - 1996

  Sandoz merged with Ciba, then became Novartis in 1997