Description
PROFESSIONAL SUMMARY * A proven leader with a track record of accomplishments with more than fifteen years pharmaceutical industry experience in leading analytical development activities for small molecule drug development * Hands-on experience in analytical project management in drug development and regulatory submissions hands- on experience in analytical method development/validation/transfer in GMP environments expertise in execution, documentation, performance and applications of analytical procedures following SOPs, protocols, cGMP/GLP, FDA regulations and ICH guidelines * Hands-on experience in coordinating analytical activities at CMO/CRO for drug substance and drug product manufactures, selecting/evaluating/guiding CROs and CMOs, supervising their performance and reviewing data and reports * Hands-on experienced with interacting with Quality Control/Assurance, Discovery, Formulation Development, Process Chemistry R&D, and Regulatory Affairs personnel * Experienced author and reviewer of regulatory documents to initiate global clinical studies and to register global products, IND/IMPD, NDA/MAA, briefing book of End-of-Phase 2, clarification, and pre-NDA meetings with FDA and at pre-MAA meetings with rapporteurs * An expert and go-to person in structural characterization of small molecular compounds using mass spectrometry and NMR, special expertise in area of impurity identification and degradation chemistry and genotoxic impurity assessment * Proven leader with track record of recruiting and developing talented employees and bringing out their best performance, supervising BS, MS and Ph.D. scientists and training associates * Strong capability of solving complex technical problems and demonstrated communication and interpersonal skills to effectively manage a vibrant and productive analytical group - * Accountable for all Analytical Development, Small Molecule (ADSM) activities to support Drug Substance (DS) and Drug Product (DP) from pre-Development Candidate stage to product launch * Manage all aspects of ADSM-related Preferred Providers relationships * Develop phase-appropriate quality control strategies for drug substances and drug products * Author or review analytical development and validation reports * In close collaboration with other CMC and Non-Clinical functions, develop and implement phase-appropriate specifications and generate specification justification reports * Work with Regulatory Affairs/Publishing Preferred Provider CMO's to author, manage, and coordinate ADSM sections for IND/CTA submissions * Work with the Director of Regulatory Affairs to: o ensure ADSM strategies adhere to current and evolving ICH and regional regulatory guidelines o contribute to phase appropriate CMC-related meetings with Health Authorities * Manage ADSM CMC-related program specific development plans and timelines 3 clinical trials to regulatory submission as well as for commercial products o Developed validated and transferred analytical methods for drug substance/product release and stability testing under GLP/GMP elucidated the degradation chemistry of drug molecules designed and conducted stability studies and set/justified specifications for drug substance/product and developed genotoxic impurity strategies n o Identified impurities in drug substances and synthetic intermediates/starting materials by LC/MS/MS in n support of process development and identified degradation products in drug products by LC/MS/MS and performed degradation pathway analyses from forced/stressed degradation studies in support of formulation development *
Accomplishments
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