Experience

Aspen Pharma Australia

• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Responsible Chemists Lead - API Quality

  • Feb 2011 - Present

  The RC Lead is heading the Responsible Chemists section in the Quality Center of Excellence of API Operations. This section (8 FTE) is responsible for the release decision for manufactured API's. To this end, the compliance items of the entire production is evaluated such as deviations and changes, process validation status, product stability, regulatory status, customer demands etc. The RC Lead is heading the Responsible Chemists section in the Quality Center of Excellence of API Operations. This section (8 FTE) is responsible for the release decision for manufactured API's. To this end, the compliance items of the entire production is evaluated such as deviations and changes, process validation status, product stability, regulatory status, customer demands etc.



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Head of Late Stage Development - API

  • Jul 2006 - Feb 2011

  Heading a Projectmanagement section for Late Development (Phase IIB and onwards) activities in API manufacturing. Heading a Projectmanagement section for Late Development (Phase IIB and onwards) activities in API manufacturing.



Organon

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Projectmanager Late Stage Development

  • 2005 - Jul 2006

  Responsible for set-up of supply chain for API manufacturing of strategic Organon Phase 3 products, including scale-up of processes, constituting regulatory dossier etc.

• Ass. Section Manager

  • 2003 - 2005

  Responsible for introduction of new processes and optimization of existing processes in chemical plant.

• Commissioning Manager

  • 2000 - 2003

  Commisioning Manager for commissioning, qualification and start-up of chemical plant



Diosynth

• Projectmanager process development

  • 1996 - 2000

  Management of several process development projects in chemical API synthesis. Management of several process development projects in chemical API synthesis.