Max Mellmer

Experience

1. Principal Scientist, Chemical Development, Cmc

   Neurocrine Biosciences

   Jul 2023 — Present · San Diego, CA, US

   Represent CMC as a lead on cross-functional project teams to communicate CMC plans and strategy and ensure alignment with global product development plans· Initiate and manage CDMO partners for process development, tech-transfer, process scale-up, and manufacturing of API for preclinical through clinical and commercial GMP supplies· Provide support for commercial manufacturing process validation activities, such as preparing and reviewing documents (master plans, protocols, and summary reports) and establishing process understanding (FMEA, DOE, PAR/NOR, fate & purge, impurities control)· Develop phase-appropriate, robust, and efficient API manufacturing processes that deliver high-quality product through R&D and optimization activities, including experimentation for compound preparation, synthetic route scouting, process development, and process troubleshooting· Perform engineering-focused process R&D and optimization of API processes including thermal hazard analysis, crystallizations, particle-size reduction (wet milling, sonication), flow chemistry, process modeling (Dynochem), and DOE (JMP)· Source, procure, install, operate, and maintain laboratory and scientific instrumentation and equipment required for chemical development activities· Support kilo-lab operations (up to 100 L scale) including equipment configuration, maintenance, and operation· Perform quality review of GxP batch manufacturing and testing data for final disposition of batches by quality assurance· Author and review CMC documents, such as regulatory filings, batch records, specifications, development and validation protocols, and product development reports ensuring scientific integrity and compliance with all regulatory requirements· Collaborate with Analytical, Product Development, Preclinical, Clinical, Regulatory, and Quality as well as other departments to facilitate communications between departments and lines, ensuring information is shared and used widely and effectively

Education

• University of Wisconsin-Madison

  Doctor of Philosophy (Ph.D.), Chemical Engineering

  2011 — 2016

• University of North Dakota

  Bachelor of Science (B.S.), Chemical Engineering

  2006 — 2011

Skills

• Science
• Research
• Characterization
• Spectroscopy
• Chemistry
• Ftir
• Nanotechnology
• Powder X-Ray Diffraction
• Materials Science
• Chemical Engineering
• Microsoft Office
• Gas Chromatography
• Analytical Chemistry
• Matlab
• Catalysis