Raj Thota, MBA, MS, BS

Founder & Principal, InnoTech BioPharm Solutions LLC
Senior Global Pharmaceutical Executive | CMC Development Leader | Operational Excellence Strategist

Raj Thota is the Founder of InnoTech BioPharm Solutions LLC, established in January 2024, providing specialized consulting in CMC (Chemistry, Manufacturing, and Controls), complex drug product innovation, and operational excellence for global pharmaceutical and biotech companies. With over 20 years of leadership experience across the U.S., Canada, Asia, and Europe, Raj has a proven track record of advancing complex drug products from concept to commercialization while driving regulatory success and market differentiation.

Raj specializes in end-to-end development of complex dosage forms, including modified-release (MR), abuse-deterrent formulations (ADF), high-potency products, and combination drug-device products. He applies Quality by Design (QbD) principles to manage risk, process control, and regulatory compliance, leveraging Process Analytical Technology (PAT) to optimize manufacturing and ensure consistent product quality.

Expertise and Achievements

• Directed 150+ global pharmaceutical products, embedding robust control strategies to ensure product performance and accelerate regulatory approvals.

• Led process innovation at Endo (Par Pharmaceutical) and Perrigo, developing advanced technologies such as Tablet-in-Tablet designs and non-screen blinding techniques, improving launch success rates by 63%.

• Delivered regulatory approvals through proactive risk management frameworks (FMEA, HACCP) and reduced global launch timelines by four months.

• Spearheaded global technology transfers at ThermoFisher Scientific (Patheon) and Adare Pharma (Frontida BioPharm), optimizing complex formulation scale-ups across CDMO sites.

• Drove operational improvements using Lean Six Sigma, achieving:

  • 200% revenue growth through streamlined site operations.

  • 71% increase in cost efficiency and 64% reduction in quality issues.

  • 25% reduction in equipment downtime and sixfold increases in batch throughput.

Strategic Vision

As Senior Vice President, Chief Manufacturing Officer, and Head of CMC at Pharnext S.A., Raj led global technical operations across U.S. and EU sites, ensuring successful CMC development, regulatory compliance, and clinical supply chain management. His strategic leadership has enabled the delivery of life-changing therapies while optimizing costs, reducing risks, and accelerating market access.

Commitment to Excellence

Raj is dedicated to bridging scientific innovation with operational strategy, guiding organizations through complex CMC challenges while delivering measurable improvements in quality, efficiency, and regulatory compliance. Through InnoTech BioPharm Solutions, Raj partners with clients to optimize development, accelerate approvals, and ensure operational excellence in delivering patient-centric solutions to global markets.