1. Technical Lead for 205 Cr Greenfield API project, Commissioning and Start up of Pilot Plant, 150 KL Manufacturing Block, Solvent Recovery Plant and Hydrogenation Block. 2. Cross Functional team management and Project coordination. 3. Engineering design, proposal and finalization of Process Equipments. 4. Working with MS- Projects, Team leading and planning skills. 5. Heading Technology Transfer and scale up of new products. 6. Process improvement and Capacity debottlenecking. 7. Led Validation team of Technology Transfer Engineers for New Products. 8. Technical support to the management for Techno Commercial decision making. 9. Kilo Lab Installation and Project work, Design, Layout, Procurement of Equipment, Installation, Commissioning and Operations start-up of Kilo Lab scale equipment for scale-up studies. 10. Azide chemistry, HN3 handling 11. Greenfield Process lead 12. Expertise in manpower management 13. Adaptable to flexible work environments
1. Manufacturing Block Commissioning, 255 Days, Greenfield API Manufacturing Block Start up, Equipments finalization, procurement, design review, installation and commissioning. Utility and Process Piping line size calculation. ETP design finalization and commissioning, SRP design finalization and commissioning
2.Scale up of Azide chemistry product, 98 Days, Sodium Azide handling and scaleup, safety studies evaluation for HN3 generation, design of hollow cylindrical jacketed vertical column for HN3 expulsion Installation and 3.Start-up of New Kilo Lab, 120 Days, Design, layout , startup, installation and establishment of New Kilo Lab at manufacturing site.
4. Scale up and Technology Transfer of Rosuvastatin Calcium, 122 Days, Scale up and Technology Transfer at Site to meet quality, yield and cost.
5. Validation at Site. Scale Up And Technology Transfer Of Lifitegrast, 121 Days, High Value, high risk, low volume critical API molecule. Successful Validation of the process parameters meeting target yield, cost and quality profile.
6.Scale Up And Technology Transfer Of Pantoprazole Sodium, 122 Days, Pantoprazole Sodium is an Proton pump Inhibitor having significant market requirements. Successfully Validated at one of the manufacturing site with Highest Yield and Quality. One of the Impurity namely Related Compound -H ( Sulfone ) is a challenging task in the product. It's limit in USP is NMT 0.20 % , With modifications in reactant addition pattern , achieved Sulfone level is below 0.05%.
7. Scale Up And Technology Transfer Of Atorvastatin Calcium USP, 153 Days, Scale up of Atorvastatin Calcium USP to the scale of 35 Times, Product involves a critical filteration of product layer that crystallizes at 40 Deg C. It is difficult to handle this layer without any support energy. A fully insulated setup was designed having double pipe heat exchange system to ensure the smooth filteration of the layer. Yield and Quality parameters achieved as per USP standards. Atorvastatin Calcium, 92 Days, Scale up of process from gram scale to commercial scale. Process includes hydrogenation, Filteration, distillation and crystallization.
8. Column Chromatography with silica gel as the adsorbent, 122 Days, Column chromatography is being done to remove impurities from an intermediate oily mass. Two columns each of height 6 metres are used for the process. Silica gel is used as the adsorbing agent along with heptane as the mobile phase. The oily mass is allowed to travel through the column thereby releasing the impurities in the silica bed. Exothermicity is observed as the oil travels down the column. The eluted oil plus heptane collected at the bottom of the column is then distilled under vacuum to recover the heptane. The mass left in the vessel is the product.
9. Compaction of material for particle size adjustment, 92 Days, FG material of low bulk density is compacted by roll compaction machine with roller rpm and feeder rpm as variable parameters. Compacted material is then milled through a multi mill and then sifted through vibro sifter. Undersize material is then tested for bulk density for a desired result, if not complies then oversize can be further processed through multi mill and vibro sifter and the new undersize can be blended with the original one
10. Fractional Distillation under high vacuum, 61 Days, Fraction distillation of alpha methyl cinnamic aldehyde under high vacuum with sulzer packing in the column of 100 Litres Glass assembly. Different cuts are being distilled as fractions and the fraction which complies in all the impurity limits is the product. Rest other fractions are taken separately as a batch to recover pure product from them also .