Josh Hoerner

Management and Development of Noramco Analytical Services Team: • New Product Development/Implementation/Technology Transfer • Analytical Research and Development/Laboratory Modernization • Commercial Plants/QC Laboratories Support • Global Supply Chain Support • Customer Technical Support • Regulatory Strategy • Reference Standard Program • CRO/CMO Management

• Lead cross-functional teams responsible for product and process development of NCEs and PVEs, containing the following groups: Preformulation, API and Product Analytical Sciences, Biopharmaceutics, Formulation Sciences, Process Technology, Clinical Manufacturing Operations, External Services, Regulatory CMC and Quality • Responsible for integrated formulation and analytical development strategy conceptualization and execution as well as transition from early to late development groups. • Lead both API and DP analytical sub-teams to support product commercialization in both early and late phase development. Responsibilities include commercial method and specification development, method validation, and method transfer. • Point-of-contact and technical lead for CRO/CMO management of GMP and non-GMP development activities, across a number of third parties both within and outside of the United States.

• Manage the day-to-day operation of the mass spectrometry lab at General Electric Global Research Headquarters. • Lead the expansion and update of mass spectrometry laboratory capabilities, propose and justify equipment purchases of UPLC-UV-MS/MS, nanoflow LC-MS/MS. • Perform method development and characterization of a wide variety of sample types including small molecule synthetic reaction mixtures, peptides, polymeric mixtures, nucleic acids, etc. • Developed infrastructure and workflow for qualitative and quantitative mass spectrometric analysis. • Design, synthesize, and characterize novel molecules for use in molecular imaging and diagnostics. • Author grants/proposals for internal and external funding for development of GE products. • Author external publications and patent applications. • Proficient in Six Sigma tools and methodology, incorporation into product design.

• Experienced working in the pharmaceutical industry as part of Analytical Research and Development, characterizing APIs • Determined correlations between solid- and solution-state structure of drug compounds with multinuclear-NMR • Ascertained the relationship between product stability and structure of polymorphs and polymorph/drug mixtures