Daniel Gomez

About Daniel Gomez

Award winning analytical chemist/pre-clinical development scientist with 20+ years of early phase pharmaceutical development experience spanning pre-clinical through Phase 2b. Experienced across a broad spectrum of disciplines and capable of supporting multiple projects at various stages of development.• 18 years of GMP/GLP analytical experience• 20+ years of physical properties / physiochemical analysis of API and drug product• Analytical project lead on multiple projects• Client facing• Supervision and training of junior staff• Experienced with solving complex analytical issues using HPLC and solid state characterization• Development and qualification of HPLC / UPLC / GC / LC-MS / qNMR methods for API and drug product• Externalization / outsourcing of API and drug product manufacture, release and stability• Generation of foundational knowledge that drives selection of tox and pre-clinical formulations while utilizing this data to influence Discovery Units’ decisions regarding portfolio progression• Formulation development to support extemporaneous compounding in clinical studies • Training of clinical pharmacists on extemporaneously compounded formulation preparations• Pharmaceutical development of pre-clinical assets, experienced with formulation development approaches for biology and safety studiesExperienced with the characterization and assessment of stability of API and drug products using HPLC, UPLC, HPLC/UPLC-CAD, GC, LC-MS, qNMR, SEC-HPLC, disintegration, dissolution, IVRT, ICP-MS, Karl Fischer, XRPD, DSC, TGA, Moisture sorption, SEM, Malvern particle size and optical microscopyKeywords: HPLC, UPLC, LC-MS, ICP-MS, Physical Properties, Pharmaceutical, GMP, GLP, NCE, Extemporaneous Compounding, Outsourcing, Method Development and Validation/Qualification, CMO, CRO, CAD

Experience

1. Principal Scientist i

   Cambrex

   Mar 2024 — Present · US

   Ensure appropriate methods and specifications are in place for raw materials, intermediates and final products to support GMP manufacturing of API while ensuring that timelines are met. Responsible for the management of the development and validation of methods to support the manufacturing of API. Author and discuss weekly updates with clients.HPLC/UPLC/GC/LC-MS/qNMR/ICP-MS/PSD method development and validation for small molecules

Education

• North Carolina State University

  Bachelor of Science (BS), Chemistry

  1999 — 2004

Skills

• Chemistry
• Analytical Method Validation
• High-Performance Liquid Chromatography (Hplc)
• Gmp
• Validation
• Glp
• Formulation
• CRO
• Pharmaceutical Industry
• Sop
• Drug Development
• Pharmaceutics
• Drug Discovery
• Ivrt
• Extemporaneous Compounding
• CMO
• Method Development
• Analytical Chemistry
• Good Laboratory Practice (Glp)
• Hplc
• Physical Properties
• Pre-Clinical Studies
• Dissolution