Ashok Rao Tunoori

President Consultant @Av Square Chem Inc

Monmouth Junction, NJ, US

AV Square Chem, Inc. provides specialized consulting services in chemical development, supporting clients from drug intermediate design and candidate selection through to commercial launch. We deliver cost-effective, customized solutions across all stages of development.• Directed and coordinated multiple Contract Development and Manufacturing Organizations (CDMOs), providing technical guidance and resolving complex manufacturing challenges• Directed and coached multiple CDMOs in phase-appropriate analytical method development for starting materials, intermediates, and drug substance specifications.• Applied Design of Experiments (DOE) and Failure Mode and Effects Analysis (FMEA) methodologies to define the Proven Acceptable Range (PAR), Normal Operating Range (NOR), Critical Process Parameters (CPP), and Critical Quality Attributes (CQA) for commercial processes.• Reviewed and approved stability protocols for drug substance batches during the development, registration, and validation phases.• Reviewed and approved Process Performance Qualification (PPQ) documentation and successfully executed a required process validation campaign.• Oversaw the manufacture of Regulatory Starting Materials (RSMs) at CDMOs• Designing final manufacturing routes using Quality by Design (QbD) principles• Transferring manufacturing processes to internal and external manufacturing site divisions• Developing and implementing new synthetic routes at lab (100G), pilot plant,(multi-KG) and commercial manufacturing levels• Medicinal and organic chemistry, with strong problem-solving capabilities• SAR, combinatorial chemistry, prodrug design, and GI-targeted delivery• PK/PD, DMPK, and integration with biological/tox data for candidate optimization• External CRO management and global collaboration• Successful advancement of multiple clinical candidates across therapeutic areas

National Chemical Laboratory, Pune, India

Ph.D., Organic Chemistry

The Martin Luther University of Halle-Wittenberg

Post-Doc, Alexander Humboldt fellowship in Germany, Organic Chemistry

The University of Kansas

Post-Doc, Organic/Medicinal Chemistry

Indian Institute of Technology, Bombay

PhD Coursework, Organic synthesis