0000-0003-0815-9238 About
Professional work summary:
Since January 2008, I have worked in the pharmaceutical industry across India and China.
Notable success in rendering strategic direction and vision for Analytical Research & Development for Formulation in the Pharma industry in alignment with organizational goals. Delivered excellence in establishing quality procedures for the Analytical Development Lab; led end-to-end functions encompassing method development, validation, troubleshooting & transfer.
• Strong understanding of new technologies & the competitive ecosystem; proven capabilities in playing an advisory role & providing thought leadership & transformation recommendations. Successfully evaluated & implemented emerging technologies, instrumentation & software tools for analytical testing & data analysis and assessed their suitability for formulation development while enhancing the capabilities for product characterization, quality assessment, cost savings & quality enhancements.
• Showcased excellence in ensuring that analytical methods are robust, accurate & reproducible, meeting regulatory requirements & supporting product development & manufacturing activities. Steered regulatory inspections & audits while ensuring timely resolution of findings and implementation of corrective & preventive actions.
• Innate excellence in strategizing, planning, executing & monitoring analytical projects, ensuring adherence to project timelines, budgets & quality standards. Skilled in steering & informing project progress, milestones achieved & potential risks or issues, and implementing mitigation strategies to ensure project success.
• Successfully collaborated closely with multiple functions encompassing Process R&D, Formulation Development, Manufacturing, Quality Control, and Regulatory Affairs to support product development & commercialization initiatives.
• People Manager with skills in recruiting, leading, training, monitoring & motivating high-performing multi-cultural teams entailing over the analytical group of Chinese technical staff entailing managers, analytical team leaders, and analytical researchers to drive research initiatives & develop new analytical.
• I have authored 27 peer-reviewed research publications and hold 20 Indian patents, with additional patents under examination. My work has directly supported globally approved oncology and specialty drug products across the United States, Europe, Canada, Australia, China, and India.
Employment
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Zhuhai Resproly Pharmaceutical Technology Co., Ltd Sr. Director & HOD2022 - Present
Education
Education history is unavailable.
Projects & Funding
Projects & funding information is unavailable.
Publications (51)
- Quality by Design‐Based Development of a Robust LC Method for Simultaneous Estimation of Process‐ and Degradation‐Related Impurities in Rifapentine Drug Product for the Treatment of Active and Latent Tuberculosis Save
- Estimation of Antimicrobial Agent (Sorbic Acid) in Semisolid Dosage Form (Gel) Using Liquid Chromatography and Evaluation of Its Stability in the Presence of Steroids, Polymers, and Low pH Save
- Development and Validation of a Stability‐Indicating LC Method for the Determination of Empagliflozin‐Related Substances With Sensitivity Profiling and Robustness Assessment Using Analytical Quality by Design Principles Save
- Quantification of 24 inorganic impurities in vismodegib and idelalisib anticancer drug substances using ICP-MS Save
- Design and Synthesis of Alpha Glycosidase Inhibitors for 1-Benzyl-4-OXA-1,9-Diazaspiro[5.5]Undecan-2-One, an Anti-Diabetic Agent. Save
- Unspecified degradation impurities identification and characterization in bilastine and montelukast tablet formulations by using UPLC and LCMS/MS: Robustness by design expert and green assessment Save
- Bioanalytical tandem mass spectrometry method for cinacalcet in human plasma: green assessment with advanced metrics Save
- 8-(Piperazin-1-YL)-3-(Pyridin-3-YL) Imidazo [1,5-A] Pyrazine and Amide Derivatives, Alpha Glucosidase Inhibitors. Save
- Unique Research for Developing a Full Factorial Design Evaluated Liquid Chromatography Technique for Estimating Budesonide and Formoterol Fumarate Dihydrate in the Presence of Specified and Degradation Impurities in Dry Powder Inhalation Save
- Method for Analyzing Budesonide and Formoterol Fumarate Dihydrate in Dry Powder Inhalers Using Full Factorial Design Evaluated Liquid Chromatography. Save