Chris Sheckler

About Chris Sheckler

Highly motivated for patients, values driven, and articulate Director (Senior Manager) with over two decades of broad-based bioanalytical experience from strategy concept to bench-top execution for multi-modalities (Cell & Gene Therapy, Mabs).*Leading bioanalytics for high value development programs within Research and Development (GLP/GCP) for Mabs, and supporting CMC residuals (process-related Impurities) for LVV and AAV based cell and gene immunotherapy programs (e.g, Breyanzi, Abecma)*Team builder, motivator, empathetic manager, mindful listener. Leading and managing residuals bioanalytical methods development, qualification/validation, transfer for CAR-T programs (e.g, Breyanzi).*Consistently delivering goals ahead of aggressive timelines by nimbly navigating challenges using the right technology platform with the ability to effectively communicate and influence stakeholders based on sound scientific principles.*Collaborate with Process Development (process improvement), Quality Control (method transfer of \'for release methods\'), Clinical. Manage and partner with CROs, CDMOs, and CTOs to execute experiments to support method development, qualification, and validation to achieve development program goals.BIOANALYTICAL LEADERSHIP • Bioanalytical Principal Investigator, Lead Bioanalytical Scientist cell immunotherapy• Keen Assay Concept, Development, Validation, Troubleshooting skills• GLP, Clinical Sample Bioanalysis• MSD ECL, AlphaLISA (and other bead based assays), Simple Plex (Ella by Protein Simple), ELISA• Bioassay, Potency, Binding Assays, Tissue Culture, Endotoxin (KQCL), Mycoplasma• LIMS (Watson), Softmax Pro• Automation (Tecan Freedom Evo 200 platform)MANAGEMENT (RESULTS ORIENTED)• Discovery, Research & Development, Pre-Clinical, Clinical Bioanalysis• Key member of Global Development Teams and Product Strategy Teams• Transfer Methods / Bioanalysis to CROs• Manage, mentor, and train Principal Scientists, Sr. Scientists, Scientist, Senior Research Associate• Contributing Scientist to IND, BLA, and other regulatory filings• Lab Management Team (representing AD) at Juno headquartersEXCELLENT COMMUNICATION• Author / Review Analytical Procedures, SOPs, Validation Plans, & Technical Reports• e-Lab Notebook; Electronic Document Management• Word, Excel, PowerPoint, Smartsheet, JMP software• Thorough GLP & GCP Knowledge• Contributor to regulatory filings: IND, BLA, Pre-clinical, and Clinical Study Protocols

Experience

1. Associate Director, Network Materials Qc, Global Quality

   Bristol Myers Squibb

   Jan 2024 — Present · Seattle, WA, US

   Lead a Global QC Team responsible for technical program and method oversight for Raw Materials and QC Critical Reagents within the Network Cell Therapy commercial and late stage development. Includes media, buffers, reagents used in drug product manufacturing as well as materials used in QC requiring testing prior to use and custom QC Critical reagent suppliers. Supporting all Cell Therapy Manufacturing sites.

Education

• University of Washington

  Biomedical Regulatory Affairs Certificate, Biomedical Regulatory Affairs

• Bellevue College

  Associate of Arts and Sciences (A.A.S.), Biology/Biological Sciences, General

• University of Washington

  Bachelor of Science (B.S.), Cell & Molecular Biology

Skills

• Principal Investigator
• Assay Development
• Sds-Page
• Immunoassays
• Antibodies
• Ecl Immunoassay
• Protein Chemistry
• Validation
• Radiation Monitoring
• Good Laboratory Practice (Glp)
• Drug Metabolism
• Drug Discovery
• Binding Assays
• Sop
• U.s. Food and Drug Administration (Fda)
• Bioanalysis
• Biopharmaceuticals
• Biotechnology
• Life Sciences
• Cell Culture
• Glp
• Lims
• Clinical Trials
• Elisa
• Bioassay
• Pharmacokinetics