Jon Schroeder

Experience

• 

  Paddock Laboratories, Inc

  Jul 2001 - Mar 2008

  Analytical Chemist
• 

  AstraZeneca

  Apr 2008 - Oct 2018

  CMC Team Leader for Pearl's PT003 dual-combination metered dose inhaler program. Accountable for the strategic planning and coordination of all CMC aspects of the development process.Author and facilitate the successful completion of CMC sections of regulatory submissionsUsing the Quality-by-Design approach, design, resource, and manage product development studies aimed at mitigating technical risks and advancing the product from phase 3 to commercial • Manage a team of researchers responsible for the analytical work associated with respiratory drug development, including clinical / tox material QC, R&D support, and stability• Coordinate the development and validation of analytical procedures used to characterize APIs, intermediates, and respirable drug products• Investigate and determine root cause of atypical/OOS laboratory results• Develop and implement phase-appropriate quality systems

  • Director, Pharmaceutical Development

    Apr 2008 - Oct 2018

  • Sr Manager, Analytical Development

    Apr 2008 - Dec 2013
• 

  Self employed

  Nov 2018 - now

  Pharmaceutical Development Consultant