Shiny Vilinda

*Analysed API stability samples and biosimilars DS and DP products

*expertise in handling of HPLC (waters, Agilent, shimadzu with empower and labsolutions software)

*independently performed calibration of HPLC and UV.

Inprocess testing of Biosimilars

 Responsible for the in-process and final purified product quality checks of bio-similars as perrequirements.

 Performed Purity analysis by SEC, IEX and affinity chromatography.

 Conducted protein concentration determinations by UV methods and RP-HPLC. Performed physicochemical measurements for pH,Osmolality, Dye ingress test and fill volume test.

 Updates of logbooks/documentation in laboratory.

 Calibration of equipments: UV spectrophotometer, Agilent and Waters HPLC, calibrated independently using LABWARE LIMS 7 software.

 Actively involved in formulation support, GLP trainings and timely temperature monitoring of lab.

 Performed lab activities as per GLP, and assisted in routine day to day activities of lab for the duly release of the bulk and formulation batches.

-Biochemistry Post Graduation:Master in Science

Mangalore St. Aloysius college, MangaloE BATCH: 2015-2017

GPA: 7.11