Cygnus Technologies, LLC
David A. Hylander, MBA has a diverse and extensive work experience spanning multiple industries. David A. is currently serving as the Director of Manufacturing Operations at Cygnus Technologies, LLC since June 2023. Prior to this, they worked at StrideBio, Inc as the Director of GMP Manufacturing Operations from November 2021 to November 2022. During their tenure at StrideBio, they led a team in developing an AAV gene therapy cGMP manufacturing process, achieving notable success in their first 1000L Engineering Batch.
Before joining StrideBio, David held various positions at Bristol Myers Squibb. David A. served as the Associate Director and Head of Business Operations where they led the Business Operations team in supporting a 350-person manufacturing operation and played a crucial role in driving alignment within the network. David A. also held positions as a Senior Manager in Operational Excellence and Continuous Improvement, where they implemented tier governance and led the deployment of this structure across the site. Additionally, they served as a Senior Manager in Aseptic Operations, where they oversaw a production team during a major line renovation.
David's career began at Celgene, where they held roles as a Manager in Manufacturing Support, responsible for managing a team and ensuring the accuracy and quality of manufacturing operations. David A. also served as a Senior Supervisor in Aseptic Operations, where they led a team in aseptic medication production with a focus on maintaining on-time production and yield.
Prior to their industry career, David served in leadership roles in the US Army, including Brigade Headquarters Company Commander in Pyeongtaek, South Korea.
Overall, David A. Hylander, MBA brings a wealth of experience in manufacturing operations, team leadership, and continuous improvement.
David A. Hylander holds a Bachelor's degree in Criminal Justice from The University of Alabama. David A. also has a Master of Science (M.S.) degree in Leadership from Grand Canyon University, as well as a Master of Business Administration (MBA) with a focus on Business Administration and Management, General, also from Grand Canyon University. In addition to their formal education, they have obtained a certification in Kepner-Tregoe Problem Solving & Decision Making (Coach) from Kepner-Tregoe in January 2016.
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Cygnus Technologies, LLC
Cygnus Technologies, part of Maravai LifeSciences, is the biopharmaceutical industry’s partner in host cell protein (HCP) and other process-related impurity detection and analytics. In addition, Cygnus now provides innovative viral clearance solutions as well. Cygnus helps companies developing therapeutic proteins, vaccines, antibodies, plasma derivatives and gene therapies to ensure the safety of biotherapeutics prior to human trials, regulatory approval and commercial release. Cygnus provides analytical tools and solutions delivering insights to improve bioprocess development for faster regulatory approval and better clinical outcomes. Cygnus is an industry pioneer responsible for developing and commercializing the first generic assay kits for HCP detection. Its reputation for quality is recognized by the industry and global regulatory agencies. It continues to advance the science of bioprocess impurity detection with new breakthroughs, including its Antibody Affinity Extraction™ (AAE) technology and orthogonal methods of HCP analysis that integrate Mass Spectrometry, AAE and ELISA. To reduce the cost and risk associated with viral clearance studies, Cygnus also offers a unique approach that utilizes non-infectious mock virus particles through its MockV™ virus clearance kits. Cygnus’ proprietary technology, available through its off-the-shelf and custom analytics programs, sets the gold standard for enabling HCP and other bioprocess impurity antibody assays. Cygnus delivers best-in-class customer service and technical expertise, operational excellence and ISO-9001:2015 certified quality management systems. Founded by Ken Hoffman in 1997, Cygnus continues to support and advance technology in order to improve biotherapeutic safety and accelerate the movement of new therapeutics through the development and regulatory approval process. Located in Southport, North Carolina, Cygnus Technologies is online at www.cygnustechnologies.com.