Ganesh Wagh

About Ganesh Wagh

Result-driven R&D professional with more than 23 years of diverse and significant…

Experience

1. Group Leader

   Piramal Pharma Ltd

   Jun 2003 — Present · Mumbai, IN

   Piramal’s Generic API division offers an indigenous basket of off-patent APIs for global markets. With the declining pipeline of new drugs in the pharmaceutical industry, The major responsibilities are,• Handling the design, synthesis, purification, and characterization of specialty intermediates and APIs.• Responsible for synthesizing impurities and confirming them using multiple techniques.• To coordinate and assist the technical team to ensure a smooth process transition from lab scale to pilot scale including all activities such as tech transfer, troubleshooting, deviation, change control, and CAPA at in-house and outsourced locations.• Designing specifications for raw materials, intermediates, solvents, and APIs in-house in coordination with the ADL team.• To provide extended support to reduce the cost of commercialized APIs and increase process throughput. • To coordinate with the RA team about DMF deficiencies and fresh DMF filings in order to strictly comply with regulatory guidelines.• Evaluating new potential DMF molecules proposed, providing project costing, development cost, budget, man-hours, and direct/indirect costs.• Decision-making during troubleshooting when issues come up during operations to scale up.• Task delegation to the team, work planning, and execution.• Preparation of the process development report & QBR.• Taking charge of a five-person team as a team leader.• Responsible for Safety representative & ERT (EH & S compliance) on the entire site.• Organize all parts of lab operations, including security, vendor management, chemical inventory, and documentation.• Establish quality assurance procedures and monitored compliance with the required standards for the product.• Manage project proposals, as well as development, accommodation, and scale-up for various MNC clients.

Education

• North Maharashtra University

  M.Sc, Organic Chemistry

  1997 — 1999

• North Maharashtra University

  B.Sc, organic chemistry

  1994 — 1997

Skills

• Synthetic Organic Chemistry
• Trained in Patent Infringement Analysis.
• Glp
• Hplc
• R&D
• Chemistry
• Gc-Ms
• Organic Chemistry
• Sop
• Sound Knowledge of Relevant Sop, Cgmp, Glp, Hse Guidelines
• Generic Programming
• CRO
• Ir
• Technology Transfer
• Process Simulation
• Pharmaceutics
• Organic Synthesis
• Familier with Analytical Tools Like Ir, Gcms, Lcms, H-Nmr &13c Nmr.
• Nmr