Gowri Naidu

General Manager & Head of R&D with 27 years of progressive experience in Chemical Process R&D, Technology Transfer, Scale-up, and API Process Development in the Pharmaceutical Bulk Drug industry. Proven expertise in process validation, APQRs, CAPAs, deviation investigations, DMF documentation, supplier audits, and regulatory compliance. Strong background in custom manufacturing projects for global innovators, filing of Indian & International patents, and applying modern scientific approaches such as QbD, DoE, FMECA, Risk Assessment & Reverse Engineering for process improvement and cost optimization.

Recognized for leading multi-disciplinary teams, resolving complex plant-level issues, and driving continuous innovation.

Sr. General Manager- Head R&D - Fleming Laboratories Ltd.

(2025-01)

General Manager – Head of R&D - Fleming Laboratories Ltd.

(2021-01 - 2025-01)

• Provide strategic leadership for R&D, portfolio management, resource planning, and people development.
• Lead product and process development, driving continuous improvement to meet safety, quality, and regulatory requirements.
• Oversight of regulatory filings, SOP preparation, product improvement portfolios (PIP), and process standards management.
• Mentor cross-functional teams to ensure compliance and efficiency in ongoing and new product development.
• Drive root cause analysis, CAPA implementation, and troubleshooting for production and regulatory challenges.

Assistant General Manager – R&D - Fleming Laboratories Ltd.

(2019-01 - 2021-01)

• Led Process Development Projects (APIs & Intermediates) under CRAMS model for multiple clients.
• Provided strong project management support across multi-site, multi-client geographies.
• Developed synthetic routes, ensured smooth scale-up and commercialization.
• Trained scientists on independent project execution, troubleshooting, and documentation.

Senior Manager – R&D - Fleming Laboratories Ltd.

(2016-01 - 2019-01)

• Conducted literature search, route scouting, and process optimization.
• Led kilo-lab & pilot plant scale-ups; supported manufacturing troubleshooting.
• Authored critical technical documents (PDRs, Tech Packs, Vendor Qualification Reports).

Deputy Manager – R&D - Fleming Laboratories Ltd.

(2012-01 - 2016-01)

• Ensured compliance with lab safety, chemical disposal, and solvent recovery procedures.
• Developed reprocessing/recrystallization methods and supported production investigations.

Assistant Manager – R&D - Fleming Laboratories Ltd.

(2007-01 - 2012-01)

• Planned and executed reactions; prepared BPRs for pilot and production scale.
• Troubleshot issues during scale-up and commercialization.

Executive / Sr. Chemist / Chemist – R&D - Fleming Laboratories Ltd. & Vasudha Pharmachem

(1997-01 - 2007-01)

• Synthesized APIs & intermediates; scale-up of lab processes.
• Conducted literature survey, NMR/MS interpretation, and purification studies.
• Mentored junior chemists and trainees.

M.Sc. - Chemistry - Acharya Nagarjuna University (2018-01 - 2020-01)

B.Sc. - MPC - Andhra University (1991-01 - 1994-01)

Chemist Training (R&D) - Vasudha Pharmachem Pvt. Ltd. (1997-01 - 1998-01)