Mitulkumar Patel

Background

About Mitulkumar Patel

Strong problem-solving and leadership skills along with a distinguished career spanning more than 8 years of experience in pharmaceutical API and product development/characterization. My extensive expertise encompasses all phases and CMC-related activities toward the development of small molecules and biologics including drug substance characterization and development, preclinical and clinical formulation design and characterization, scale-up, and commercial manufacturing along with relevant regulatory documentation. Compound selection: Hit-to-Lead transition based on its Physico-chemical parameters Solid-State Characterization: Phase origin/purity determination, thermal stability determination Solid form selection: polymorph/salt screening, form evaluation, and form selection API crystallization development and scale up: Process efficiency and robustness optimization by right solvent and process parameter selection/optimization. Enabling technology implementation: Preparation, optimization, and evalution of Spray Dried Dispersion (SDD) and Hot Melt Extrusion (HME) materials Preclinical (animal) formulation development: PK study design, data analysis and formulation optimization to increase exposure Formulation development: Quality by Design (QbD) approach to achieve critical quality attributes (CQA) by optimizing critical material attributes (CMA) and critical process parameters (CPP), with focus on amorphous, extended release, and gastro-retentive formulations Clinical Manufacturing: GMP unit operations, formulation and process development, novel product/process development, tech transfer and scale up/commercialization External vendor management: GLP tox/GMP clinical studies/analytical studies at managed external vendors to enhance quality, reduce cost, and meet the timeline CMC regulatory documentation: Regulatory affairs certification with experience in documentation for regulatory requirements including cGMP, safety, process/product development report, eCTD requirements for Module 1, Module 2, and Module 3 Quality work with aggressive timeline: Deliver quality product by timely initiation and completion of activity milestones along with identifying and focusing on critical path with line of sight Efficient project and operation management: Strong verbal/written communication and organizational skills with ability to effectively multi-task along with global time zone flexibility Team oriented: Skilled in leveraging resources and cross- functional team members to generate synergy and maximize work efficiency and output