Daniel Genov
Senior Director, Process Chemistry Cmc @Praxis Precision Medicines, Inc.
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WORK HISTORY
Senior Director, Process Chemistry Cmc @Praxis Precision Medicines, Inc.
EDUCATION
Washington University in St. Louis
Postdoc, Asymmetric Catalysis
University of Staffordshire
Ph.D., Organic Chemistry
SKILLS
ABOUT DANIEL GENOV
Proven technical development and operations leader with broad chemistry, manufacturing and controls (CMC) background from preclinical development through validation. Expertise in internal and external process development, drug substance manufacturing and supply chain management. Established and managed relationships with contract research and manufacturing organizations (CRO/CMO) globally. Hands-on problem solver with appreciation for balancing business needs/risks while maintaining scientific excellence. Strong knowledge of CMC regulatory requirements with contribution in writing regulatory documents. Thorough knowledge of small molecule drug substance development. Strong communication, organizational, negotiation and leadership skills. Core competences and experience include:• Process R&D route development, scale-up and optimization.• CMO/CRO selection, technology transfer and process validation.• CMO/CRO management and cGMP manufacturing.• Leading process development technical teams.• Leveraging internal vs. external resources to improve speed, cost, quality, and technology advantage.• Phase appropriate cGMP and GLP requirements.• Contracts and IP strategy.
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