Experience

Leadiant Biosciences, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Manager, Regulatory CMC., North America

  • Aug 2020 - Present



Provetica LLC (a Ceva AH Co.)

• Ballwin, MO

• Senior Manager - CMC

  • Feb 2019 - Dec 2019

  Generic pharma - Companion animal products, expert level role responsible for implementing CMC strategy for generic drug dev. projects - dosage form development management of the CDMO's Generic pharma - Companion animal products, expert level role responsible for implementing CMC strategy for generic drug dev. projects - dosage form development management of the CDMO's



HUVEPHARMA, INC

• United States
• Veterinary Services
• 100 - 200 Employee

• Regulatory Affairs Manager - CMC

  • Nov 2016 - Jan 2019

  Product development & CMC - generic large animal products - US- oral liquids, medicated feeds, solids; coordinate with CMO's manufacturing & analytics; CMC- ANADAs Product development & CMC - generic large animal products - US- oral liquids, medicated feeds, solids; coordinate with CMO's manufacturing & analytics; CMC- ANADAs



Merial

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Manager, CMC World Wide Pharmaceuticals, Global RA

  • Sep 2007 - Nov 2016

  CMC New projects - FDA-CVM, EU EMA, US- EPA; emerging markets; pre-development & pre-submission FDA- CVM meetings; CMC New projects - FDA-CVM, EU EMA, US- EPA; emerging markets; pre-development & pre-submission FDA- CVM meetings;



Merck AH

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Pharmaceutical Development Coordinator, New Product Development, R&D

  • Dec 2001 - Sep 2007

  Product Dev. & CMC - Companion & large animal; coordinate with CMO's manufacturing, analytics and packaging, soft chew development, PAT application and scale up's Product Dev. & CMC - Companion & large animal; coordinate with CMO's manufacturing, analytics and packaging, soft chew development, PAT application and scale up's



Thermo Fisher Scientific

• United States
• Biotechnology Research
• 700 & Above Employee

• Development Scientist / Sr Scientist, Non Sterile Solids, R&D

  • Jun 2000 - Dec 2001



Teva Pharmaceuticals

• Israel
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Formulation Scientist, - R&D Pharmaceuticals

  • Nov 1997 - Jun 2000



SPIMACO

• Saudi Arabia
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Technical Development Specialist, Technical Services & Development

  • Jan 1994 - May 1997