Grant Munson Email and Phone Number

- Drug Product Lead for late-stage oncology asset sitravatinib, charged with advancing development and manufacturing efforts from registration through pre-PPQ and preparation for commercial launch.- Key role in tech transfer of Krazati drug product to 2nd manufacturing site.- Developed manufacturing process for 2nd generation, high drug load tablet formulation.- Function as person-in-plant for development and manufacturing batches at CMOs.- Oversee Continued Process Verification for commercial product.- Developed tracking tools to monitor and dashboard drug product quality attributes.- Responsible for in-house process development, process scale-up, tech transfer, and technical oversight of commercial operations of Mirati assets at various CMOs.- Author and review various CMC sections of the NDA, focusing on Drug Product and Container Closure using eCTD.- Design primary and functional secondary (wallet) packaging configurations.- Function as technical support in primary and secondary product packaging activities.- Design experimentation (DOE) and execute small/pilot scale laboratory trials.- Work with contract sites to design process development technical batches and supervise the execution.- Author and review of GMP documentation, such as experimental reports, batch record review, development, and technology transfer reports.- Perform process monitoring and data trending of key attributes using statistical analysis.- Lead investigations/OOS related to processing to identify root causes and corrective actions.- Facilitate FMEAs between Mirati and manufacturer using a Quality-by-Design approach.- Independently design experiments and carry out scientific work.

- Drug Product Lead for Sitravatinib, late-stage oncology asset, charged with advancing development and manufacturing efforts from registration through pre-PPQ and preparation for commercial launch.- Function as person-in-plant for development and manufacturing batches at CMOs.- Oversee Continued Process Verification for KRAZATI (Adagrasib) commercial product.- Support in-house process development, process scale-up, tech-transfer, and commercial operations of Mirati assets at various CMOs.- Author and review various CMC sections of the NDA, focusing on product development and packaging.- Function as an SME in primary and secondary product packaging activities.- Design experiments and carry out scientific work, including authoring or review of GMP documentation, such as experimental reports, batch record review, development, and technology transfer reports.- Perform process monitoring and data tracking and trending of key attributes using statistical analysis- Lead investigations/OOS related to processing to identify root cause and corrective actions.- Maintain up-to-date scientific knowledge through regular literature review and participation in conferences

• Design experiments for technical batches, perform scale-up and feasibility activities for solid oral drugs • Oversee processes to improve small molecule drug solubility and formulation manufacturability • Analyze, evaluate, and interpret various product physical characteristics • Lead technology transfer process and perform technical review of manufacturing batch records to identify risks • Support manufacturing group in GMP production areas as a subject matter expert • Prepare reports, summaries, procedures, SOPs, and technology transfer documentation • Regular client interaction and extensive interdepartmental interaction • Lead process and equipment troubleshooting efforts • Continuously develop pharmaceutical process knowledge • Identify, research, and onboard new equipment and technology

- Oversaw operation, maintenance, validation, and cleaning of two pharmaceutical spray drying plants used for GMP productions- Resolved production deviations/non-conformances and generated CAPAs using Root Cause Analysis tools- Supervised engineering assistants- Evaluated and procured new equipment through capital expenditures (CapEx)- Provided technical support and engineering oversight to complex GMP productions- Identified potential manufacturing processes and procedural improvements- Developed preventative maintenance programs and spare parts inventories for manufacturing equipment- Generated SOPs, IQ/OQs, calibration protocols, and technical reports- Worked cross-departmentally with, MFG Ops/Logistics, Quality Assurance, Process Engineering, Metrology, etc.- Designed fixtures to optimize production equipment

- Performed validation protocols (IQ/OQ) and TOC cleaning verification on GMP equipment- Wrote standard operating procedures, validation protocols, and technical reports- Supported in spray drying R&D work, including GEA Mobile Minor setup and preparation of spray solutions- Assisted in manufacturing pre-production activities such as sampling, material prep, and equipment setup- Generated client/visitor facility maps and evacuation signage- Worked with Engineering group to troubleshoot and maintain manufacturing equipment - Coordinated monthly calibration testing with outside vendors

- Tutored in mathematics, language arts, social studies, physical science and life science, grades K-8

- Assisted Facilities Team in converting new building zoned for warehouse to manufacturing- Provided production support in part assembly, powder coating, laser engraving, and CNC mill/lathe operation