John Schiel Email & Phone Number

I am a research chemist in the NIST Biomolecular Measurement Division and on detail to the Advanced Manufacturing National Program Office (AMNPO) as the Technical Program Manager for NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals (the NIST-sponsored Manufacturing USA institute). As the NIIMBL Technical Program Manager, I am a technical partner in advancing the NIIMBL-funded American Rescue Plan projects that contibute to US prevention, preparedness, and response to the coronavirus pandemic. I also coordinate with NIST, federal stakeholders and the NIIMBL community to maximize opportunities to contribute to advancing biomanufacturing technologies that positively impact patient health. My research lab develops Reference Materials that support the biomanufacturing industry and coordinate thier implementation in broad collaboration with industry, academic, and federal stakeholders. I am very proud to have led the recombinant IgG1κ NIST monoclonal antibody Reference Material 8671 (NISTmAb). More importantly, I am thankful each day for the broad biomanufacturing community contributions and their innovative drive that conributed the material's utility and success. Establishing the NISTmAb as an industry standard was truly an ecosystem-wide collaborative success. In addition to the NISTmAb quality control and lifecycle management, my analytical research team develops innovative approaches toward characterization of next generation biotherapeutics (e.g. viral vectors, cell therapy products, and vaccines) and de-risking of innovative technologies for lifecycle appropriate implementation and regulatory assimilation. Biomanufacturing and characterization of the ever increasing cadre of complex modalities (protein therapeutics, Antibody-drug conjugates, bispecifics, fusion proteins, vaccines, etc.) are approaching a turning point where disruptive technology may be necessary to advance the next generation. Each molecular class brings with it new challenges in elucidation of structure, mechanism of action, stability, and immunogenicity. Such analytical and biochemical challenges are coupled with regulatory considerations that must be met to ensure safety and efficacy. I look forward to developing innovative approaches toward characterization of next generation biotherapeutics, structure-function correlations, and de-risking of innovative technologies for lifecycle appropriate implementation and regulatory assimilation.

Listed skills include Hplc, Chromatography, Mass Spectrometry, Affinity Chromatography, and 8 others.