Yogesh Sonawane

Highly motivated process chemistry leader with over eight years of industrial experience in process chemistry, tech transfer, and GMP manufacturing of drug substances (DS). Strong leadership and technical skills necessary to collaborate with cross-functional teams to advance chemical development and quality-based GMP risk assessment. Ensured DS manufacturing strategies adhered to current and evolving ICH and regional regulatory guidelines. In-depth knowledge of manufacturing equipment and technologies, as well as chemical plant operations, to support preclinical, clinical, and commercial programs. Expertise in leading, troubleshooting, and providing guidance to internal or external process chemists, strong project management and communication skills, and experience with early and late-stage (Phase 3 and NDA) activities.

• Managed the phase-appropriate development and manufacturing of small molecule APIs in accordance with applicable quality and regulatory standards.
• Strong knowledge of CMC strategy development for raw material selection & characterization, analytical method development, impurity profiling, product/equipment specifications, and stability protocols following US FDA, EMA, and ICH guidelines.
• An expert in cGMP with in-depth knowledge & experience in route design, process development (PD), process optimization, technology transfer, scale-up from the laboratory to pilot plant/production scale.
• Experience working with both early and late-stage (phase 3, commercial) programs, including process validation, CPPs, and QbD.
• Strong manufacturing experience: USFDA/ICH guidelines, GMP principles, process characterization & validation, process control strategy, quality management system.
• Technical expertise in controlled crystallization, particle-size distribution, reaction scale-up, and batch processes.
• Strong experience working with multidisciplinary teams, including analytical, QA, QC, EHS, manufacturing technology, supply chain, production, business development, and project management.
• Expertise in identifying key process parameters, applying techniques for the purification of APIs, the origin of impurities, and appropriate process controls.
• Extensive experience in authoring, reviewing, and approving high-quality reports and summary documents for regulatory submissions.
• Authored, reviewed, and approved process chemistry protocols (tech. transfer, safety, cleaning, corrosion, incident reporting, ELN), master batch records, PD reports, and technology transfer documents for manufacturing processes for internal and external clients.
• Participated in process validation and INDA and NDA support.
• Expertise in identifying, designing, & implementing continuous flow processes.
• Performed a detailed DOE, PAR, NOR, CPP/CQA analysis, F&P, and spiking studies.
• Proficiency in experimental designing & scale-up tools: State-Ease (DOE software), Dynochem (unit operation modeling and scale-up prediction software), & Chetah 11.0 (thermochemical prediction software), Waters (NuGenesis) laboratory management system.

• Process for the separation of 4-bromomethyl-2-substituted biphenyls from 4,4’-dibromomethyl -2’- substituted biphenyls., Rohit Chaturvedi, Shrikrishna Vengurlekar, Yogesh Sonawane, WO 2008/078340 A1, http://calyx-pharma.com/api.pdf
• A class of quaternary ammonium catalysts., Ganapati Shankarling, Yogesh Sonawane, 1129/MUM/2011
• Structure-Activity Relationship Studies with Tetrahydroquinoline Analogs as EPAC Inhibitors., Yogesh A. Sonawane, Yingmin Zhu, et al., ACS Medicinal Chemistry Letters, 8, 11, 1183-1187, 2017
• Cyclin-dependent kinase 9 inhibitors for cancer therapy., Yogesh A. Sonawane, Margaret A. Taylor, et al., Journal of Medicinal Chemistry, 59, 19, 8667-8684, 2016
• Synthesis of diphenylamine-based novel fluorescent styryl colorants by Knoevenagel condensation using a conventional method, biocatalyst, and deep eutectic solvent., Yogesh Sonawane, Sunanda Phadtare, et al., Organic Letters, 12, 7, 1456-1459, 2010