Nilakantha Jena Email and Phone Number

Analytical Method Development, Method Validation, Method Transfer and Registration Stability Studies.Certified Investigator of Quality Management system (OOS/OOE and Deviation)Analytical stratgey and planning for product with respect to timeline, Budget and Agile approach for handling the complex Product.Team Planning and Build collaborative culture make the effective and Highly performing TeamEnsure Timely completion of Analytical Task with respect to product… Show more Analytical Method Development, Method Validation, Method Transfer and Registration Stability Studies.Certified Investigator of Quality Management system (OOS/OOE and Deviation)Analytical stratgey and planning for product with respect to timeline, Budget and Agile approach for handling the complex Product.Team Planning and Build collaborative culture make the effective and Highly performing TeamEnsure Timely completion of Analytical Task with respect to product deliverables.Responsible for Compliance of Laboratory system and Activeley involved for multiple corporate Quality Audit and USFDA Audit Show less

Senior Scientist in Analytical DevelopmentKey Team player in Analytical Method Development, Validation and Transfer to Multiple Global NTO site.Assessment study for shelf life determination for Clinical Phase -1, phase -II A and Phase II B product.Evaluate Analytical Method and Specification for Registration batches of Product and execute Registration stability studies for submission Batches.Assessment for defined storage condition of product based upon various… Show more Senior Scientist in Analytical DevelopmentKey Team player in Analytical Method Development, Validation and Transfer to Multiple Global NTO site.Assessment study for shelf life determination for Clinical Phase -1, phase -II A and Phase II B product.Evaluate Analytical Method and Specification for Registration batches of Product and execute Registration stability studies for submission Batches.Assessment for defined storage condition of product based upon various exploratory studies of New chemical entity.Prepare Analytical package for IND filling at various Health Authority for initiation of Clinical trial for NDA product. Show less

* Working on Oncology project for solid oral dosage forms.* Handling of Analytical tool @ GLIMS ( for Analytical result entry and analytical report, Tracking of calibration and maintenance of analytical instruments Stability Sample loading and pull out from stability chamber). @ TEDI ( Preparation Analytical Method, Validation protocol, report, Validation summary, Method transfer report, Stability protocol for Review and approve by QA). @ Chromelon ( Online… Show more * Working on Oncology project for solid oral dosage forms.* Handling of Analytical tool @ GLIMS ( for Analytical result entry and analytical report, Tracking of calibration and maintenance of analytical instruments Stability Sample loading and pull out from stability chamber). @ TEDI ( Preparation Analytical Method, Validation protocol, report, Validation summary, Method transfer report, Stability protocol for Review and approve by QA). @ Chromelon ( Online documentation and result calculation for HPLC and GC).@ AQWA ( Handling of Deviation, OOS, OOE and OOT and SST failure case during product life cycle)* Preparation of DRS (Drug stability report).* planning and execution of method validation and routine activity for analysis of stability samples.* New laboratory set up ( Qualifaiction of Analytical instrument ( Preparation URS, IQ/OQ/PQ document and review and approval from QA and execution of qualification activity aligned with service engineer.* Preparation of Lay out and diagram of laboratory area and Temperature and humidity mapping of laboaratory and Maintenance of BMS aligned with service engineer.* Evaluation of Analytical instrument life cycle and retirement report of analytical instrument.* Implementation of HSE requirement in lab as per the HSE guidelines.* Preparation and revision of SOP as per the new requirement of USP and EU and Japan guidleines. Show less

# Analytical method Development,validation,method transfer for Solid dosage form, Suspension,ointments and opthalmic products.# Analytical method development on Assay and Degrdation product, Dissolution, Residual Solvent and elemental impurities, and cleaning method validation by Swab on plate recovery.# Method Validation and method transfer of Analytical method such as Assay, Degradation products, Dissolution,Residual Solvents by GC, Cleaning Validation by swab… Show more # Analytical method Development,validation,method transfer for Solid dosage form, Suspension,ointments and opthalmic products.# Analytical method development on Assay and Degrdation product, Dissolution, Residual Solvent and elemental impurities, and cleaning method validation by Swab on plate recovery.# Method Validation and method transfer of Analytical method such as Assay, Degradation products, Dissolution,Residual Solvents by GC, Cleaning Validation by swab technique.# Review of analytical raw data and preparation of method development and validation protocol, method transfer protocol, and method validation and transfer report.# Preparation of SOP and qualification document for Analytical instrument such as HPLC, Dissolution, IR, GC, Weighing Balance, PH meter, Stability chamber, Freezer, Coulometer, and Karl-Fischer instrument.# Bi- Annual Calibration of analytical instruments such as HPLC (Waters, Agilent, schimadzu, Nexera) Dissolution apparatus ( Electrolab, LabIndia,Venkel, Sotax with Autosampler technique) GC (Agilent), Stability chamber (Newtronic), PH meter (Metrohm), UV-Visible Spectrophotometer ( Thermo scientific), Weighing balance ( Mettler Toledo).# People management having team size of 4 memebers involving for various analytical activities. Show less

Method development for dissolution technology.