Andrew Hudacek
ProteinSimple Quality Control
- Role
- Senior Manager, Quality at Bio-Techne
- Location
- Farmington, CT, US
- LinkedIn followers
- 500 followers
About Andrew Hudacek
I am an experienced research scientist with a background in molecular biology, virology, vaccine development, protein engineering and antibody discovery against GPCRs and other integral membrane proteins using phage display and later in immunoassay development with the Luminex platform. Following nearly 20 years focused on research and product development, I transitioned into the Quality Control realm as the Manager of the Analytical Services group, viral clearance team ProteinSimple reagent QC and Biosafety Committee Chair. These experiences have allowed me to further develop experiences in quality, regulatory, manufacturing and project management. Recipient of Bio-Techne\'s 2020 President’s Innovation Award (Bio-Techne/Kantaro SARS-CoV-2 assays and products).
Experience
Senior Manager, Quality
Jul 2025 — Present · Wallingford, CT, US
ProteinSimple Quality, SimplePlex and SimpleWesternBiosafety committee chairperson Lead quality strategy and operations for multiple Bio-Techne product lines generating $200M+ annual revenue, overseeing incoming QC, product release, and complaint investigations. Manage multiple teams responsible for quality control testing of Simple Plex and Simple Western product lines, ensuring compliance with internal standards and external regulations. Lead and champion annual cross-functional improvement projects, delivering a 25% reduction in labor (FTE) for Simple Western testing through process optimization. Lead complex investigations and corrective actions addressing diluent manufacturing challenges impacting $214M in revenue, collaborating with raw material suppliers, QC, supply chain, and manufacturing teams to secure supply continuity and quality compliance. Foster a culture of quality excellence and continuous improvement through coaching, talent development, and cross-departmental engagement.
Education
University of Minnesota
Bachelor of Science, Microbiology, General
Mayo Clinic Graduate School of Biomedical Sciences
Doctor of Philosophy (Ph.D.), Virology and Gene Therapy
2006 — 2012
Mayo Clinic
Doctor of Philosophy, Virology
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