Daniel Genov

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.

Experience

1. Senior Director, Process Chemistry Cmc

   Praxis Precision Medicines, Inc.

   Oct 2025 — Present

Education

• Washington University in St. Louis

  Postdoc, Asymmetric Catalysis

  1998 — 2000

• University of Staffordshire

  Ph.D., Organic Chemistry

Skills

• Drug Discovery
• Organic Synthesis
• Biotechnology
• Good Laboratory Practice (Glp)
• Purification
• Gmp
• Life Sciences
• Organic Chemistry
• Pharmaceutical Industry
• Drug Design
• Drug Development
• Chemistry
• Technology Transfer