Shailendra Mandge

About Shailendra Mandge

Patience and perseverance are keys to success. This is a quote that has found its practical manifestation in my professional journey. Seasoned Scientist, bringing thought-provoking perspectives in setting up & and managing cost-effective formulation development, Scale-up, Validation, Qualification, Technology Transfer, Registration, and Launch of Generics/ New Chemical Entities (Small and large Molecules) in regulated and non-regulated markets. Throughout my career, I have successfully forged Technology Partnerships, finalized CMO/ CRO/ Labs, drove R&D, Analytical Chemistry, and Innovation. Preparation of SOPs/ Protocols, Reports, Technical Documents, and Regulatory Requirements for Filing in the US MarketA commercially driven dynamic go-getter, with expertise in Technology Transfer from R&D - lab to pilot scale production, commercialization, and launch of high-quality Products in various - Oral Solid/Liquid, Hard and Soft Gelatin Capsules and Parenteral Dosage Forms, positioning the company as a Reliable Pharma Brand, gain customer delight, business, and revenue growth. Partnered with International Project Teams to facilitate Pharmaceutical Development in external collaborations. The merit of numerous Research Papers, Paper Presentations, Patents, and NDA Filing as per QbD concepts.Recognized by Seniors as a Focused Leader and problem-solver and by Colleagues and friends as Collaborative and Trustworthy always willing to help people. I strongly believe in the values of Integrity, Honesty, and Discipline, with a strong commitment to shape abstract ideas into realistic plans, manage challenging tasks, and deliver exemplary results. I have led and mentored teams with an equal desire to win.I like cooking, reading books, listening to podcasts, and watching inspiring movies.Key Milestones: During my present association with Eurofins Advinus Biopharma Services India as Associate Director and Head of Formulations; managing all Oncology & Non-Oncology Compounds across Pre-Clinical, Clinical, and Generic Developmental Stages, including 505 (b)(2) and First to File (FTF) Pathways Received: Star Award in 2015, 2017, 2018 and 2020 for optimization and development of Phase Clinical Formulation, support to NDA Filing, CDS Management and BMR Reviews for Biologics Drug Substance (DS) & Drug Product (DP) Significant Achievement Award in 20••••10 for development of complex molecules Applied Quality by Design (QbD) Methodologies, Quality Risk Management Framework, Pharmacokinetics, In-Vitro Dissolution and Bioequivalence Studies for optimum results

Experience

1. Associate Vice President

   Granules India Limited

   Aug 2024 — Present · Hyderabad, IN

   Formulation development

Education

• Pacific University Udaipur

  Doctor of Philosophy - PhD

• Rajiv Gandhi Prodyogiki Vishwavidyalaya

  M.Pharm, Pharmaceutical Chemistry

  2003 — 2005

• Government higher secondary school, sagar

  Biology/Biological Sciences, General

  1994 — 1996

• Rajiv Gandhi Prodyogiki Vishwavidyalaya

  B.Pharm, Pharmaceuticals

  1998 — 2002

Skills

• Formulation
• Regulatory Submissions
• Formulation Development
• Pharmaceutical Industry
• Sop
• Fda
• Regulatory Requirements
• Ind
• Analytical Chemistry
• Generic Programming
• Standard Operating Procedure (Sop)
• Hplc
• Analytical Method Validation
• Liquid Chromatography-Mass Spectrometry (Lc-Ms)
• Design of Experiments
• Manufacturing
• Uv/Vis
• Pharmaceutical Research
• Validation
• Medicinal Chemistry
• CRO
• Uv
• Ir
• Organic Chemistry
• Drug Development
• Bioanalysis
• Biopharmaceuticals
• Good Laboratory Practice (Glp)
• Pharmacokinetics
• Regulatory Affairs
• Lc-Ms
• Abbreviated New Drug Application (Anda)
• Dissolution
• Glp
• Usp
• Cleaning Validation
• Pharmacology
• Chromatography
• Anda
• Gmp