PROFESSIONAL HIGHLIGHTS:
Pharmaceutical professional with 18+ year industry experience in Scientific and Management role. Expertise in various dosage forms like Nasal, Topical pharma, US Generic and OTC products, Aerosol, Oral care product formulation & manufacturing technologies for US/EU//Brazil/India/ROW Market. Proven track record in leading and managing projects from early formulation development through to commercialization, for both in-house manufacturing and external partnerships including CDMO, CRO, and CMO collaborations. Skilled in external site evaluations, third-party manufacturing assessments, and technology transfers, ensuring seamless execution and regulatory compliance and Due-diligence for external site and manufacturing plant Certified PMP® and PM (IIT) to lead & Management of project from initiation of development till commercialization for In-house manufacturing and CDMO/CRO/CMO
EXECUTIVE PROFILE:
Research & Development:
- Expertise in all types of products such as Nasal, Topical, US generic and OTC, Oral care, Ophthalmic, OSD, Personal care products, Aerosol and exposure to global regulatory requirements such as: US/EU//Brazil/India/ Emerging Markets/ROW etc.
- Successfully developed and commercialized Nasal product for Abbott, P&G, GSK, Walmart, Merck, Glenmark, DRL, Zydus, Cipla, Lupin and others
- Successfully developed, execution of scaleup batches and commercialization of Topical products with different study approaches like PARA IV, Q1/Q2/Q3, IVRT/ IVPT, Skin blanching, Biowaiver, CGT, DESI and Clinical study.
- Filed more than hundred for USA, Europe, Brazil as well as India market & received approvals
- Served as Head of Nasal Drug Delivery, providing strategic and technical leadership for nasal formulation development (Sava Healthcare Ltd)
- Lead a Team of 4 Vertical Manager and 22 Scientist for product development and scale up (Pontika).
- Managing & guiding laboratory execution, feasibility, optimization, scale up and exhibit batch manufacturing as well as trouble shooting at each stage
- Formulation development, optimization and Scale Up up to commercialization.
- Implementation of QbD concept and Design of Experiment (DOE).
- Review work progress to achieve project milestones and Successfully development, execution of scaleup batches and commercialization products.
- Handling of regulatory queries and providing support for the response submissions.
End-to-End Project Leadership: Driving formulation development from concept to commercialization for both internal and outsourced projects. Technology Transfer: Expertise in seamless tech transfer processes between R&D, pilot plants, and manufacturing sites (in-house or external).
CDMO/CRO/CMO Collaboration: Managing strategic partnerships for product development, scaleup, validation, and commercial manufacturing. Handled for national and international CMO and CDMO clients to support development and project transfers activities including project tracking and connecting to CFTs to meet the Clients project execution timelines.
External Site Evaluation: Conducting technical audits, capability assessments, and compliance reviews of third-party manufacturing sites.
Due Diligence: Evaluating potential partners for technical, operational, and regulatory fit to ensure robust outsourcing decisions.
Project management: Experienced in planning & project management from early stages to commercial stage for Abbott, GSK, RV Health Philippines, Sun Pharma, STADA, Dr. Reddy’s
CORE EXPERTISE:
Nasal Care Formulation – Nasal sprays, Nasal Drops, Nasal Mist, Saline-based solutions, Metered dose nasal and targeted nasal delivery for US/EU/DCGI/India Market Key achievement of Nasal Formulation:
Abbott:
- DCGI Metered dosed steroid products Approval within time frame
- Solspray (Isotonic Nasal spray_BOV Technology)
- Sodium chloride Metered dose nasal spray
Glaxosmithkline:
- Otrivin Nasal Advance metered Spray
- Otrivin Pedriatric Oxy nasal spray
- Otrivine Nasal Spray
PNG:
- Oxymetazolin+Dexpanthanol Metered Spray
- Oxymetazolin Nasal Spray
Wallmart:
- Equate Saline Nasal Spray
- Equate Saline Pediatric Nasal Spray
Merck:
- Nasivion Pedriatric Nasal Spray
Cipla:
Lupin:
DRL:
Steroidal Nasal Products: For US/EU/Developed for Glenmark, Zydus, IH Development.
USFDA approval of CGT product Creams, Emulsions, Ointment, Gels, Foams, Sprays, Solution : US/EU/Brazil/ROW/India
- Worked on different topical bases for various drug molecules and filed for US/EU/Brazil/Row/India Market
- Successfully developed, execution of scaleup batches and commercialization of Topical products with different study approaches like PARA IV, Q1/Q2/Q3, IVRT/ IVPT, Skin blanching, Biowaiver, CGT, DESI and Clinical study.
- Received USFDA approval within timeline of Gold period (Within 10 M),
- USFDA approval of CGT product, USFDA approval of Para IV product and Successfully handled USFDA regulatory deficiencies and received approval of more than 30 Topical products
US OTC Product Development – FDA-compliant formulations Developed & commercialized multiple US OTC products, ensuring FDA compliance and successful market penetration
Liquids – Worked on Solution, Suspensions, emulsion as well as Microemulsion, Multivitamin, Syrup, Oral solution, Oral liquids etc.
Oral Care – Medicated toothpastes, mouthwashes, and mucoadhesive gels
Aerosol & Spray Technologies – Metered-dose sprays, foams, water-based aerosols, and continuous spray delivery
IN-HOUSE MANUFACTURING & EXTERNAL PARTNERSHIPS (CDMO/CRO/CMO)
End-to-End Project Leadership: Driving formulation development from concept to commercialization for both internal and outsourced projects.
CDMO/CRO/CMO Collaboration: Managing strategic partnerships for product development, scale-up, validation, and commercial manufacturing.
Technology Transfer: Expertise in seamless tech transfer processes between R&D, pilot plants, and manufacturing sites (in-house or external).
External Site Evaluation: Conducting technical audits, capability assessments, and compliance reviews of third-party manufacturing sites.
Due Diligence: Evaluating potential
Regulatory & Quality Alignment: Ensuring all processes and sites (internal or external) meet cGMP, US FDA, EU, and other global regulatory requirements.
Cross-functional Coordination: Liaising with QA, RA, Supply Chain, and Commercial teams to ensure alignment and timely execution.
Cost Optimization & Efficiency: Identifying opportunities for cost savings, capacity utilization, and process efficiency across internal and partner facilities.
Present Organization: AGM Sava Healthcare
Total Experience: From Sept 2025 to till date
Past Organization: AGM Pontika Aerotech
Total Experience: From Feb 2023 to Aug 2025
Past Organization: Torrent Pharmaceutical (Manager)
Total Experience:From Aug 2015 to Feb 2023
Past Organization: Zydus Cadilla (Deputy Manager)
Total Experience: From March 2012 to Aug 2015
Past Organization: Glaxo Ltd, Nashik (Executive)
Total Experience: From Aug 2011to Feb 2012
Past Organization :Glenmark Pharmaceutical Ltd, Nashik. (Officer)
Total Experience: From July 2007 to Aug 2011.
Past Organization: Cipla Ltd. (Officer)
Department: Quality Assurance (ANDA)
Total Experience: From Jun 2006 to Jun 2007.
PhD (Doctor of Philosophy): Pharmaceutical Sciences in the faculty of Medicine from
Sant Gadge Baba Amravati University, Amravati, Feb 2015.
M.PHARM: Master’s Degree in Industrial Pharmacy from Sudhakarrao Naik Institute of
Pharmacy, Pusad. Dist- Yavatmal, Aug- 2004.
B. PHARM: Bachelor’s Degree in Pharmacy from Government College of
Pharmacy, Amravati (Amravati University, Aug- 2002).
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