Shital Pathak

About Shital Pathak

With over three decades of experience, my expertise lies in analytical method development, validation, and transfer for APIs and dosage forms. I have expertise in regulatory and quality functions as well. As Senior Vice President of Analytical Research and Development at Glenmark Pharmaceuticals, my focus includes overseeing analytical development, method validations across nine global sites, and managing an In-vitro Biostudy Lab. My work is firmly grounded in GLP standards, ensuring robust quality, regulatory compliance, and laboratory practices. At Glenmark, I lead initiatives supporting the development of OSD, dermatology products, and complex/peptide injections. My goal is to advance analytical capabilities in pharmaceutical research, with an emphasis on technology transfers, stability studies, and impurity profiling. By fostering collaboration across global teams, I am committed to driving innovation and delivering high-quality solutions that align with organizational goals.

Experience

1. Professor of Practice

   MIT World Peace University

   Jul 2024 — Present · Pune, IN

   Doing this as a passion and contribute to academia in addition to my current professional assignment with Glenmark

Education

• Panjab University

  M Pharm, Pharmaceutics

  1994 — 1996

• Nagpur University

  B.Pharm, Pharmaceuticals

  1990 — 1994

Skills

• Technology Transfer
• Regulatory Submissions
• Dissolution
• Pharmaceutics
• Drug Discovery
• Andas
• Regulatory Affairs
• Pharmaceutical Research
• Validation
• Hplc
• Formulation
• Chromatography
• Anda
• R&D
• Method Development
• Gas Chromatography
• Analytical Chemistry
• Genotoxic Impurity Method Development
• Characterization
• Nda
• V&V
• Generic Programming
• Pharmaceutical Industry
• Sop
• Gmp
• Glp
• Drug Delivery
• Drug Development