Kunesh J

1. Handling of Hollow fibre membranes ( Microfiltration/Ultrafiltration), spiral wound filters, casette membranes, Regeneration of filter membranes and their storage. 2. Handling of Biorad NGC, AKTA Pure, Prime Chromatography systems. 3. Buffer preparation of wide ranges. 4. Handling various types of chromatographic columns (Hiscale, quik scale,XK), Chromatographic processes (HIC, AEX, CEX, IMAC) and SGC, NAL & TLC. 5. Handling Rotary evaporator ( 50mL to 20L scale). 6. Performing Normal Phase Chromatography with a variety of solvents for purification of small molecules. 7. Protein quantification/estimation by Bradford's method. 8. Handling homogenizer for cell lysis of various biomolecules. 9. SDS PAGE Gel Casting, Running, staining procedures and Gel Doc. 10. Performing batch centrifuge and small scale centrifuge. 11. Performing biomolecule extractions using a wide range of organic solvents (2L to 75L). 12. Scaled up small molecule process development from 2L to 100L. (Bench scale to pilot scale) 13. Performing filtration and their regeneration. 14. CIP of columns, membranes and filters. 15. Prepared, authorized and implemented GLP compliant SOPs for Instruments and Equipments while transferring to a new Small Molecule Facility. Process Development for Purification of small molecules, peptides and large molecules.

1.Having Hands-on experience in Chromatography systems like PALL 600LPH, Novasep, BioRad, columns (Quick scale)and processes like HIC, AEX, IMAC, CEX. 2. Packing, unpacking and evaluation of column Chromatography. 3. Have handled Microfiltration processes like Depth filtration and sterile filtration with various sizes of filters. 4. Ultrafiltration and Dia Filtration(TFF concentration,Buffer exchange,Regeneration). 5. TFF Membrane cassettes fitting and removal, NWP of filter membranes and it's calculations as per SOP. 6. Performing Filter Integrity Tests like DiffusionTest, Bubble point Test and Water Intrusion Test of various types of filters and membranes. 7. Have performed the most number of Aseptic Formulation Batches in single year in the Production Team. 8. Having Hands-on experience in running Continuous and Batch Centrifuge, and CIP of the same. 9. Handled Preparatory RP-HPLC (industrial-scale - LC200 & LC 80), with resins like C8 and C18, calculating HETP and performing regeneration as per SOP. 10. Been a part of Scale-Up of Recombinant Teriparatide which is in Clinical trial stage as of now. 11. Preparation of stock buffers and working buffers upto 500L 12. Having Hands-on experience in operating Rotary evaporators also known as SpeedVac. 13. Performed Lyophilization (Freeze Drying)of Drug Substance, Loading and Unloading of Lyo trays and operation of Lyophilization cycles as per the given product BMR. 14. Having experience in writing Differential pressure and Temperature/Relative Humidity Log books of different rooms in Downstream area and complying to GMP. 15. Completion of BMR, and its corresponding documents and Log books online following GDP. 16. Have handled 6 products including 2 commercial products (Recombinant Streptokinase and Recombinant Liraglutide) which are Recombinant therapeutic proteins ranging from 50L to 400L batch sizes. 17. Initiation and execution of Batch process, raising incident, deviation, taking CAPA and involvement in QMS.