Karen De Jongh

Experience

• 

  Garvan Institute of Medical Research

  Jan 1985 - Jan 1986

  Research Officer
• 

  Macquarie University

  Jan 1986 - Jan 1988

  Postdoctoral Fellow
• 

  University of Washington

  Feb 1988 - Jun 1994

  • Research Assistant Professor, Pharmacology

    Jul 1990 - Jun 1994

  • Post Doctoral Fellow

    Feb 1988 - Jun 1990
• 

  Cell Therapeutics, Inc

  Jul 1994 - Dec 1995

  Senior Scientist, Protein Chemistry
• 

  ZymoGenetics, Inc

  Jan 1996 - Dec 2010

  Director of downstream processing and in-process anlaysis

  • Director, BioProcess Development

    Jul 2006 - Dec 2010

  • Principal Scientist, BioProcess Development

    May 2002 - Jun 2006

  • Senior Scientist, BioProcess Development

    May 2000 - Apr 2002

  • Senior Scientist, Protein Chemistry

    Jan 1996 - Apr 2000
• 

  ZymoGenetics, A Bristol Myers Squibb Company

  Jan 2011 - Jan 2019

  In-Process Analysis, Analytical Development, Characterization, Quality Control, Reagent Generation Director of downstream processing and in-process analysis

  • Director, Analytical Development and Testing

    Oct 2014 - Jan 2019

  • Director, BioProcess Development

    Jan 2011 - Sept 2014
• 

  Self-employed

  Jan 2019 - now

  Consultant,KarDventures LLC

  Expertise in advancing protein therapeutics from preclinical to clinical development and on to validation, commercial licensure and post approval support. Skilled at preparing CMC regulatory submissions and supporting documentation for pre-IND, IND, BLA and post approval stages. Served as an integrated development team leader with demonstrated success in deciding strategy, defining goals, maintaining program momentum, reaching key milestones expeditiously, ensuring on-time deliverables and effectively managing resources across multidisciplinary CMC teams. Experience managing high performing downstream processing, in-process analysis, characterization, analytical development and quality control teams. Additional areas of expertise include the following:• Regulatory submissions• Technical authoring• Information organization• GxP Compliance• Manufacturer selection, oversight• Analytical development, validation, transfer, oversight• Quality control, cGMP testing• Workflow optimization• Extended characterization, comparability, CQAs, impurities• Drug substance process development• Process transfer, validation• Drug substance manufacturing• Site-closure project out licensing Show less