Experience

AM-Pharma

• Netherlands
• Biotechnology
• 1 - 100 Employee

• Senior Director CMC

  • Apr 2021 - Present

  Utrecht, Netherlands AM-Pharma strives to develop treatments for patients confronted with severe medical conditions. AM-Pharma’s lead product candidates are currently in early-stage clinical development. As Senior Director CMC I am responsible for clinical-stage and late-stage CMC development and manufacturing of drug substance and drug product. Specifically: ➢ Management of CMC development from early clinical stages through commercial launch ➢ Clinical drug substance and drug product… Show more AM-Pharma strives to develop treatments for patients confronted with severe medical conditions. AM-Pharma’s lead product candidates are currently in early-stage clinical development. As Senior Director CMC I am responsible for clinical-stage and late-stage CMC development and manufacturing of drug substance and drug product. Specifically: ➢ Management of CMC development from early clinical stages through commercial launch ➢ Clinical drug substance and drug product manufacturing planning and coordination ➢ Clinical supply management ➢ Contribute to the development of the commercial manufacturing strategy ➢ Lead the CDMO selection and -management ➢ Coordination with partners and stakeholders (e.g. CMC, regulatory, quality, clinical, commercial) ➢ Delivering CMC sections of regulatory submissions (e.g. IND/IMPD, BLA/MAA) Show less



Venn Life Sciences - part of hVIVO plc

• United Kingdom
• Research
• 1 - 100 Employee

• Senior Consultant CMC

  • Sep 2015 - Mar 2021

  Breda Area, Netherlands Strategic leadership and operational support in Chemistry Manufacturing and Controls (CMC) of biologics, from pre-clinical to Phase III and commercialization. Clients included biotech start-ups as well as global biopharma. Areas of expertise and responsibility: ➢ CMC project management and line management ➢ CDMO selection and outsource management ➢ Delivering CMC sections for regulatory documents including IMPD/ IND and MAA/BLA ➢ Subject matter expert upstream process… Show more Strategic leadership and operational support in Chemistry Manufacturing and Controls (CMC) of biologics, from pre-clinical to Phase III and commercialization. Clients included biotech start-ups as well as global biopharma. Areas of expertise and responsibility: ➢ CMC project management and line management ➢ CDMO selection and outsource management ➢ Delivering CMC sections for regulatory documents including IMPD/ IND and MAA/BLA ➢ Subject matter expert upstream process development ➢ Technical Due Diligence ➢ Developing drug development plans Show less



Batavia Biosciences

• Netherlands
• Biotechnology
• 100 - 200 Employee

• Project Manager CMC

  • Nov 2013 - Aug 2015

  Leiden, the Netherlands Program management of pre-clinical and Phase I/II customer programs; CMC development and (GMP) manufacturing of biologics.



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior group leader cell culture development

  • Apr 2011 - Sep 2013

  San Francisco Bay Area Leading CMC efforts for monoclonal antibodies and therapeutic proteins, through early- and late stages of development including tech transfer and scale- up for (commercial) manufacturing. Support of regulatory submissions. Line management responsibilities.

• Manager upstream process development and Principal scientist

  • Aug 2008 - Apr 2011

  Weesp, the Netherlands Leading CMC development efforts for cell culture-based and egg-based Influenza vaccines. Annual update of the marketed Influenza vaccine(s) and manufacturing support. Support of regulatory submissions. Line management responsibilities.



Crucell

• Biotechnology Research
• 1 - 100 Employee

• Senior scientist

  • May 2004 - Jul 2008

  Leiden, the Netherlands As team lead responsible for the development of pre-clinical and Phase I/II upstream- and downstream production protocols for recombinant proteins and vaccines.



TNO

• Netherlands
• Research Services
• 700 & Above Employee

• PhD student

  • 1999 - 2004