About 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.
Experience
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.
Education
-Biochemistry Post Graduation:Master in Science
Mangalore St. Aloysius college, MangaloE BATCH: 2015-2017
GPA: 7.11
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