Network Member at Gerson Lehrman Group (GLG) (2025-12 – Present)
- Provide strategic technical leadership for global product launches, regulatory alignment, and commercialization.
- Mentor SMEs across Oncology, GLP-1, Hormonal therapies; drive due diligence and cross-functional precision.
- Direct multimillion-dollar project plans, budgets, and ANDA-aligned development pathways.
- Lead CMO/CDMO selection, supplier qualification, and global sourcing strategy.
- Establish enterprise QA governance, SOP frameworks, and surveillance audit programs.
- Implement KPI-driven operational excellence and quality metrics.
Lead Associate – QA & Compliance at Dr. Reddy's Laboratories (2023-12 – 2025-11)
- Directed QA/QC systems for pharma and dietary supplements; ensured full FDA, GMP, and ISO 9001 compliance.
- Led internal/external audits with zero major findings; executed risk assessments and inspection readiness.
- Managed global CMO/CPO/CTL quality performance; authored Quality Agreements.
- Oversaw batch release, ingredient verification, and analytical integrity for complex portfolios.
- Reduced product defects 90% and improved team compliance 95% through SPC and targeted training.
- Built documentation systems for CAPA, OOS/OOT, deviations, and stability protocols.
- Partnered with Manufacturing, Supply Chain, and R&D to drive cost-efficient quality improvements.
Pharma, Cosmetic & Dietary Supplements Consultant at Independent Consultant (2023-06 – 2023-11)
- Led QbD-driven development using DoE/OFAT to optimize CMAs, CPPs, and CQAs.
- Directed plant operations, construction, utilities, equipment installation, and IQ/OQ/PQ qualification.
- Executed global tech transfers across US, Canada, EU, and India.
- Built robust QMS frameworks (Change Control, CAPA, Validation).
- Designed scale-up strategies improving manufacturability and commercial performance.
- Strengthened CMO partnerships and competitive benchmarking for market alignment.
Associate Director – Projects & Technical Services at Bionpharma Inc. (2020-01 – 2023-05)
- Directed 25+ concurrent projects from concept to commercial launch ($1M–$5M budgets).
- Integrated QbD and ANDA requirements into Product Development Plans.
- Led vendor negotiations and global stakeholder alignment.
- Mitigated technical risks and supported exhibit batch manufacturing.
- Co-Developed Intelence (Etravirine) equivalent via continuous clean & green fusion granulation.
- Implemented reporting frameworks for executive visibility and milestone tracking.
Pharma, Cosmetic & Dietary Supplements Consultant at Independent Consultant (2018-01 – 2019-12)
- Delivered 60% operational efficiency improvement through process re-engineering.
- Led parenteral QMS and documentation for injectables (sterility, E&L, CCI).
- Directed facility construction and qualification (IQ/OQ/PQ).
- Built enterprise compliance programs and risk-based decision frameworks.
- Managed plant operations using KPI-driven performance systems.
Director – Technical Operations at US Pharma Labs Inc. (2014-11 – 2017-12)
- Launched 26 products and stabilized 14 formulations using QbD/PAT.
- Achieved 45% productivity gains and $750K annual savings.
- Delivered 100% order fulfillment and zero backorders for 3 years.
- Managed global CMO operations (China, India) ensuring cGMP compliance.
- Reduced inventory discrepancies 40% and strengthened supply continuity.
- Led ERP implementation improving data accuracy and workflow efficiency.
Director – Scientific & Technical Affairs at Guardian Drug Company (2008-07 – 2014-10)
- Developed/launched 40 products, driving revenue from $22M to $120M (26% CAGR).
- Re-engineered 30 product lines, reducing conversion costs 40–60% and saving $2M annually.
- Qualified new vendors, reducing costs 30% and capturing $5M savings.
- Directed multimodal dosage development (oral, topical, nasal).
- Built and led QMS (CAPA, APR, Change Control) and authored regulatory responses.
- Strengthened compliance across ISO, GxP, FDA, HIPAA frameworks.
- Built global research partnerships and contributed to patent strategy.
Senior Manager – R&D and QA at Medico Labs Inc. (2003-07 – 2008-06)
- Developed and scaled 29 products, growing revenue from $0.5M to $8M.
- Managed CMO manufacturing for capsules and topicals; launched 7 products generating $2.6M.
- Led master formula, specification, and SOP development.
- Oversaw analytical method validation and QC operations.
- Improved supplier performance 95% through CAPA and root-cause analysis.
- Achieved zero major findings in FDA/GMP/ISO audits.
Ascending Roles to General Plant Manager at Warner Hindustan / SOL Pharma / SIRIS / Micro Labs / Medreich / Vivimed Labs (1984-05 – 2003-06)
- Led CMOs supporting Bayer, Sandoz/Novartis, SmithKline Beecham, Wyeth, LUPIN, CIPLA.
- Managed 50–400 personnel across production, QA, engineering, and supply chain.
- Passed TGA, RSA GMP, MHRA, WHO GMP, ISO audits.
- Developed oral solids, liquids, aseptics, intermediates, and sustained-release systems.
- Standardized processes for 70 herbal products.
- Co-developed novel shampoo-based hair dye with Hindustan Lever/Unilever Thai.
