Guhan Chowdary
Principal Scientist | Formulation Development, Scale-Up & Regulatory Strategy – Solid Oral Dosage | Project Leadership | ANDA Query & Audit Management
- Role
- Principal Scientist at Hibrow
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Guhan Chowdary
Pharmaceutical formulation leader specializing in Solid Oral Dosage Forms (Tablets & Capsules) with core expertise in scale-up, regulatory strategy, and end-to-end project execution.Currently heading multiple formulation programs with full accountability for technical robustness, timeline adherence, and cross-functional execution. Reporting directly to the Chief Scientific Officer.Key areas of expertise include:• Scale-up and process optimization from pilot to commercial manufacturing• Resolution of complex formulation and dissolution failures• Expertise in technical response to regulatory queries (ANDA and other submissions)• Direct interaction with regulatory auditors during inspections• Project leadership across R&D, QC, QA, AD, and RA functions• Driving fast-track, compliance-aligned product developmentFocused on building scalable, audit-ready, and commercially reproducible formulations through disciplined execution and regulatory clarity.
Experience
Principal Scientist
May 2025 — Present · Chennai, IN
Leading multiple solid oral dosage formulation programs with full accountability for technical robustness, regulatory alignment, and cross-functional execution. Reporting directly to the Chief Scientific Officer.Key responsibilities & impact:• Spearhead scale-up and process optimization from pilot to commercial manufacturing• Lead technical response for regulatory queries (ANDA submissions and post-filing clarifications)• Personally handle regulatory auditors during inspections and technical discussions• Drive cross-functional teams across R&D, QC, QA, AD, and RA to ensure milestone adherence• Resolve complex formulation and dissolution failures under aggressive timelines• Oversee process validation, exhibit batches, and commercialization readiness
Education
PSG College of pharmacy
Bachelor of Pharmacy (B.Pharm.), M. Pharm
2009 — 2013
SVV hosur
HSC, Higher secondary
2007 — 2009
PSG college of pharmacy
Master’s Degree, Pharmaceutics and Drug Design
2013 — 2015
Skills
- Life Sciences
- Research and Development
- Pharmaceutics
- Manufacturing Scale-Up
- Andas
- Regulatory Affairs
- Anda
- Public Speaking
- Gdp
- Pharmaceutical Industry
- Microsoft Office
- Gmp
- Drug Delivery
- Sop Development
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