Thomas Hakansson

Experience

• 

  Københavns Universitet - University of Copenhagen

  Sept 2005 - Aug 2010

  Master Degree Student

  Faculty of pharmaceutical sciencesProject: Inhibition of Insulin Fibrillation

• 

  The Danish State Serum Institute

  Oct 2007 - Mar 2008

  Student Assistant

  Visual control of vaccines and handling of batch documentation

• 

  Nykøbing Sj. Apotek

  Feb 2009 - Jul 2009

  Student Assistant (Jus)

  Performed medication reviews and handled clients in the pharmacy

• 

  Novo Nordisk

  Jan 2011 - Jan 2019

  • Analytical QA responsible for both early and late phase development projects.• Validation/Qualification of laboratory methods/equipment (incl. IT, GAMP 3).• Member of laboratory cross-functional focus groups• CMO documentation review.• Internal audits/Inspections.• Stability protocols/reports. • API Purification processes and laboratory.• Batch status assignment, APR, PPQ.• Internal/external audits/Inspections.

  • QA Professional, CMC Analysis QA

    Sept 2014 - Jan 2019

  • QA Chemist, DAPI QA

    Jan 2011 - Sept 2014
• 

  Ascendis Pharma

  Feb 2019 - now

  As the Head of Quality on an innovative ophthalmology project, I oversee the transition from the toxicology phase to clinical phase 1. I lead a dedicated team managing a complex supply chain involving CMOs, CROs, and other vendors, ensuring compliance with GxP standards (GMP, GLP, GDP, GVP). Led a QA team in clinical development, overseeing daily operations and strategic decision-making to ensure quality and compliance. My role balanced hands-on management with critical, project-impacting decisions, driving our success in meeting clinical development objectives As part of an internal program at Ascendis Pharma, I relocated to the Redwood City site, California to work closely with the oncology portfolio.• Lead auditing of CMO/CLO/CRO• Internal audits/Inspections.• Analytical QA responsible for both early and late-phase development projects.• CMO documentation review (QAA/Change Controls/Deviations/Stability/Laboratory investigations)• Validation/Qualification of laboratory methods/equipment• Regulatory filings (BLA/NDA/IND) • Lead auditing of CMO/CLO/CRO• Internal audits/Inspections.• Analytical QA responsible for both early and late-phase development projects.• CMO documentation review (QAA/Change Controls/Deviations/Stability/Laboratory investigations)• Validation/Qualification of laboratory methods/equipment

  • Senior Director

    Mar 2024 - now

  • Associate Director, Lead, QA Development – US

    Dec 2022 - Mar 2024

  • Senior Specialist, QA Development, Chemistry

    Mar 2022 - Nov 2022

  • Manager, QA Development, Analytical

    Feb 2019 - Feb 2022