Sanjay Wagh

More than Twenty nine years of experience in Formulation development from well-esteemed organizations and having exposure to Generic product development for Global markets, Novel drug delivery system, Quality by design, Analytical development, Technology Transfer, NCE product development, Intellectual property rights (IPR) and Regulatory affairs. Currently working as Senior Vice President – Head Formulation development (Orals, Injectables, Ophthalmics and TT-IL/OL) in Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, India.

• Leading the Global Formulation and analytical development for Oral Solids, Liquids, Injectables, Ophthalmic dosage forms and technology transfer for IL/OL products.
• Expertise in Oral solid dosage forms (Tablets, Capsules, Softgels, Powders, Sachets etc.), Oral suspensions/solutions, Injectable suspensions/solutions, Lyophilized powders, Nebulizers, Nasal solutions, Ophthalmic solutions/suspensions.
• Development of MUPS, Multi-particulate dosage forms, OROS, FDC’s, Nano milled formulation’s, Oral peptides etc.
• Complex generic solid oral dosage forms requiring API sameness and IVBE studies (including iron compounds, polyallylamines etc).
• Complex Injectables like Peptides, Iron compounds, Microspheres, Liposomes and Depot injections.
• Complex Ophthalmic suspensions with IVBE/CT requirements.
• NCE-1, Para IV, CGT filings.
• Expertise in formulation development for Global markets - US, EU, India (Domestic), Canada, Australia, Brazil, Japan, Russia and Emerging markets.
• Responsible for Strategic planning, Delivering product pipeline as per plan, Providing Technical guidance to team & management, Managing MIS, Team building & People development, Ensuring smooth technology transfer from R&D to commercial, CIP’s and Troubleshooting of the process challenges, Managing capex and budget, Evaluation of new technologies, Support business development for due diligence and CRO/CMO evaluations for IL/OL products.
• Led the formulation development, analytical development, quality assurance and project management in previous assignment at Dr.Reddy’s Laboratories Ltd.
• Led the development of PEPFAR/GIB portfolio for ARV’s and formulation development for Japan market in previous assignment at Lupin Ltd.
• Supporting portfolio with technical and commercial inputs in selecting the development pipeline.
• Institutionalized QbD based development with the objective of Process robustness, Scalability and Regulatory requirements.
• Leading QbD team for all the dosage forms includes OSD, Injectables, Nasal & Inhalations, Dermal dosage forms.
• Providing support for new product launches and routine commercial operations through QbD scalability inputs.
• Initiated PAT & continuous manufacturing efforts.
• Overseen the Digital Platform Implementation in Formulation R&D with the use of Electronic Lab Notebook and advance inventory management system for effective resource utilization and compliance.
• Experience in setting up the new development labs and managing compliance activities for R&D function.
• Management of GMP pilot plant with Schedule-M compliance in liaison with local FDA.
• Expertise in managing the Contract Research with the objective of formulation development, scale up and regulatory support to Innovator companies for their NCE’s, LCM and 505b (2) opportunities.
• Expertise in managing development of NCE formulations from preclinical stage up to commercialization including CMC support for regulatory filing.
• Expertise in handling products requiring containment, like cytotoxic molecules, hormones and steroids.
• Experience in supervising manufacturing operations in Tablet, Capsule and Liquid orals dosage forms.

• Filed multiple PCT & provisional patent applications on different formulations (~15).
• Published review article on ‘Oral disintegrating tablets.
• Book chapter in NanoBioMedicine Journal, Vol.2:Nano Pharmaceuticals, titled as 'Holistic Development of Nanopharmaceutical Products: Pilot plant and Scale up studies'.
• Junior Research Fellowship, University Grant Commission (UGC), Government of India, New Delhi for post-graduation studies (two years, 1995-1996).
• Project leader for Lupin’s first branded product in US market.
• Approved as technical person for Tablet manufacturing from FDA Maharashtra.
• Project guide for seven M. Pharm students.
• Recipient of Leaders Category award at the FDD conclave-2019 organized by Express Pharma (Indian Express group).

• Date of Birth: 05/06/73
• Nationality: Indian
• Marital Status: Married

Wife (Interior designer), Daughter (Pursuing Computer Eng.) & Son (Pursuing BPT)