Syner-G BioPharma Group
Katie Winder has a diverse work experience in the pharmaceutical industry. Katie currently serves as the Associate Director of Quality and Compliance at Syner-G BioPharma Group since May 2022. Prior to this, they worked at GSK as a Quality Compliance Manager from November 2021 to May 2022. Katie also held the position of Director of Quality at ALI Pharmaceutical Manufacturing from April 2018 to July 2021. Before that, they were a Quality Assurance Manager at American Laboratories, Inc. from June 2017 to July 2018. Katie Winder started their career at GSK as an Internal Auditor from May 2015 to June 2017. Katie began working in the pharmaceutical industry in 2005 at Novartis, where they held various roles including Technical Writer / Finished Product Quality and Surveillance from May 2012 to May 2015, Quality Control Analyst II from June 2009 to May 2012, and Quality Control Analyst I from December 2005 to June 2009.
Katie Winder completed their Bachelor of Science degree in Biology, General from the University of Nebraska-Lincoln. Katie attended the university from 2002 to 2005.
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Syner-G BioPharma Group
Syner-G BioPharma Group provides in-depth expertise across the three key elements of Chemistry, Manufacturing, and Controls (CMC): Regulatory Services, Technical Development, and Quality/IT. We call this CMC 360™. We also provide medical writing services, with expertise in authoring a variety of regulatory documents across a wide range of therapeutic areas and in all phases of development. Our regulatory affairs services include the development and implementation of global regulatory strategic plans, regulatory agency meeting support, and electronic submissions to regulatory authorities around the world. We have the skill set and experience to guide your prime asset through any development challenges and along the ever-changing maze of regulatory filing pathways, to a position of full compliance, and high quality. Our expertise spans small molecules, peptides, oligonucleotides, biologics, monoclonal antibodies, antibody-drug conjugates, and cell and gene therapy products.