Dr. Andrea Kramer

Executive Director, Supply Chain Management at Develco Pharma Schweiz AG
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Location
CH

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Beat Schweizer

Excellent relationship in connection with end to end supply chain understanding. Andrea was great to get our site to an MRP Class A standard.

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Experience

    • Switzerland
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Executive Director, Supply Chain Management
      • Feb 2018 - Present

      Head of Supply Chain Management and Artwork Team Member of the Executive Board of Develco Pharma AG , Switzerland Managing supply chain related to API and packaging material procurement and dosage form production Managing supply chain to licence partner companies Quality oversight and Transfer /Validation oversight related to contract manufacturing in Switzerland ( FvP) Responsible Person for trading with controlled drugs (VP) Head of Supply Chain Management and Artwork Team Member of the Executive Board of Develco Pharma AG , Switzerland Managing supply chain related to API and packaging material procurement and dosage form production Managing supply chain to licence partner companies Quality oversight and Transfer /Validation oversight related to contract manufacturing in Switzerland ( FvP) Responsible Person for trading with controlled drugs (VP)

    • Head MS&T
      • Oct 2012 - Dec 2017

      Head of site Manufacturing Science &Technology team Set up of team and introduction of new department at the site Managing strategic design and execution of manufacturing and packaging process and cleaning validation Introduction of continued process verification and process understanding Managing technical Transfers and Scale up for product handover from development Manufacturing Process Improvements and its implementation Head of site Manufacturing Science &Technology team Set up of team and introduction of new department at the site Managing strategic design and execution of manufacturing and packaging process and cleaning validation Introduction of continued process verification and process understanding Managing technical Transfers and Scale up for product handover from development Manufacturing Process Improvements and its implementation

    • Technical Project Leader
      • Jan 2011 - Sep 2012

      Managing technical develeopment at technical project leader ( chemical, analytical and pharmaceutical development) of early phase projects Late phase pharmaceutical development, product handover to commercial production Technical life cycle management Managing technical develeopment at technical project leader ( chemical, analytical and pharmaceutical development) of early phase projects Late phase pharmaceutical development, product handover to commercial production Technical life cycle management

    • Switzerland
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Pharmaceutical Development , Formulation expert, Team leader
      • Feb 1998 - Dec 2009

      Laboratory Head in pharmaceutical development ( early and late phase) Formulation expert and departemental project leader Late and early phase pharmaceutical development of oral dosage forms for small molecules and poorly soluble APIs Coordination of scale up and transfer of drug product processes to pharmaceutical production including process validation ( Global validation and handover coordinator) Introduction of lean aspects in development and quality by design procedures Laboratory Head in pharmaceutical development ( early and late phase) Formulation expert and departemental project leader Late and early phase pharmaceutical development of oral dosage forms for small molecules and poorly soluble APIs Coordination of scale up and transfer of drug product processes to pharmaceutical production including process validation ( Global validation and handover coordinator) Introduction of lean aspects in development and quality by design procedures

    • Switzerland
    • Biotechnology Research
    • 700 & Above Employee
    • Plant Production Manager
      • 1995 - Jan 1998

      Plant manager of the Coating Facility within Solid Dosage Form ProductionProcess expert for film and sugar coatingPharmaceutical expert for solid dosage form productionIntroduction of lean six sigma elements in pharmaceutical production

    • Pharmaceutical Development
      • 1992 - 1995

      Laboratory Head in pharmaceutical development ( late phase) Process development and scale up for solid dosage fromsHandover to commercial production including process validationRepresentation of pharmaceutical development in US FDA and EMA pre-approval inspections

Education

  • Ludwig Maximilains University Munich
    PhD Pharmaceutical Technology, Dr. rer. nat
    1987 - 1992
  • Albert-Ludwigs University of D-Freiburg
    Pharmacy, Staatsexamen , German Approbation
    1982 - 1987

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