Yves Stauffer

Experience

• 

  Université de Genève

  Jan 1998 - Jan 2001

  Post Doc Scientist in Immunology

  > Molecular and cellular research in auto-immunity (Type I diabetes). mastering mammalian cell culture as well as molecular and immunological techniques (recombinant cell line generation, generation of transgenic mice, FACS, proliferation assays, PCR)> Published work: Interferon-induced endogenous Superantigen: a model linking environment with autoimmunity (Immunity, 15:591-601, 2001).

• 

  Ludwig Cancer Research

  Jan 2001 - Jan 2004

  Post Doc Scientist in Bioinformatics / SIB

  > Conception, design and administration of a Relational Cancer Immunome database in framework of the 5th European Research Program> Supervision of the work of bioinformatic experts for the launch of the relational database> Research Project: Mapping of Human Endogenous Retroviruses (HERVs) in the human genome using bioinformatic tools and approach (Cancer Immunity 4:2-18, 2004)

• 

  Baxter International Inc.

  Jan 2004 - Jan 2007

  Research Associate, Technical Services Cell Culture

  > Project Leader of successful process improvements at commercial scale that lead to significant yield Improvement for the ADVATE franchise> Significant contribution to the writing of the regulatory file in context of submissions to Regulatory Agencies> Participation and support to multiple regulatory audits (FDA, EMEA, Corporate)

• 

  Baxter International Inc.

  Feb 2008 - Dec 2014

  Senior Process Scientist, Technical Operations Cell Culture

  > Project Leader and Project Management for large scale process and product yield improvement projects> FVIII protein product expert> Six sigma Green Belt certified> Lead or support investigations using six sigma methodology and tools (CAPAs, process deviations)> Define and review product characterization programs in case of process changes, or process deviations > Define experimental design at laboratory scale and ensure good scientific quality reporting of the Technical Services Cell Culture laboratory (process improvements, CAPAs, investigations)> Contribute to defining process validation strategy in collaboration with Quality Engineering Show less

• 

  Baxalta

  Jan 2015 - May 2016

  Manufacturing Product Owner BAX111 and BAX703, Technical Operations Recombinant

  Manufacturing Product for Bax111 and HID0703. See position above for description (Global Product Lead)

• 

  Shire

  Jun 2016 - Jul 2018

  TS Global Product Lead Vonvendi and HID0703

  In 2018, CMC Lead for Vonvendi (rVWF)As the owner of these recombinant products, the Global Product Lead is responsible for:> The life cycle and the Continuous Improvement Plan for the recombinant proteins that will ensure the expected product output in the next ten years defined by Marketing and Supply Chain.> The process parameter Risk Assessment (PFMEA) that identifies the Critical Process Parameters (CPPs) that potentially impact the Citical Quality Attributes (CQAs) or Process Consistency Indicators (PCIs) following the QBD approach.> Product Reviews and Monthly Product Performance reporting > Identification of process and product improvement opportunities to increase process yields or Robustness.> Process Harmonization between Manufacturing sites> Technical support during CAPAs, investigations and Troubleshooting.> Contributing and approving Regulatory submissions and answering questions from regulatory agencies or during Audits. Show less

• 

  Incyte

  Aug 2018 - now

  • Associate Director, Bioplant Process Sciences

    Sept 2021 - now

  • Associate Director, Head of Manufacturing Science and Technology

    Aug 2018 - now