Shiny Vilinda
@shinyvilinda
Pharmaceutical analytical specialist in quality control focused on stability studies, biosimilars testing, and instrument calibration.
What I'm looking for
I am a pharmaceutical analytical specialist with over four years of hands-on experience in quality control, stability studies of APIs, in-process testing of biosimilars, water testing, and instrument calibration. I apply GMP/GxP and strong documentation practices to ensure product compliance and data integrity.
At Tribocare, I manage microbiology and water chemistry testing including ion chromatography, GC-FID, GC-ECD, and IDEXX methods for microbial assays. Previously at Biocon Biologics I performed in-process and final product testing for biosimilars with expertise in SEC, IEX, affinity chromatography, RP-HPLC, UV methods, and LIMS-based instrument calibration.
During my tenure at Anthem Biociences I led stability programs for APIs including HPLC assays, water content, potentiometry, IR for structure ID, optical rotation and melting point analysis, stability protocol preparation, and stability report generation. I also handled deviations, CAPA, change controls and OOT/OOS investigations.
I am skilled in operating and qualifying a wide range of analytical instruments (HPLC/UHPLC, GC, UV-Vis, IR, Karl Fischer, DSC, TGA, polarimeter) and software (Empower, Chromeleon, LabSolutions, Labware/LIMS). I seek to bring disciplined, detail-oriented analytical capability and continuous improvement mindset to a quality-focused pharmaceutical organization.
Experience
Work history, roles, and key accomplishments
Chemist - Quality Control
Tribocare
Jan 2023 - Present (2 years 9 months)
Conduct water chemistry and microbiology testing including anion analysis by ion chromatography, nitrate/nitrite by Skalar, hydrocarbons by GC-FID, haloacetic acids by GC-ECD, and microbiological assays (E. coli, Enterococci, Legionella, HPC) with full documentation.
Executive - Quality Control
Biocon Biologics
Nov 2020 - Jul 2022 (1 year 8 months)
Performed in-process and final quality testing of biosimilars including purity analysis by SEC/IEX/affinity, protein quantification by UV/RP-HPLC, physico-chemical tests and instrument calibration using LabWare LIMS to support timely batch release.
Scientist - Quality Control
Anthem Biociences
May 2018 - Oct 2020 (2 years 5 months)
Led stability studies for APIs performing HPLC assay/purity, water content, potentiometry, IR, optical rotation and melting point analyses, prepared stability protocols/reports, and managed deviations, CAPA, OOT/OOS investigations.
Education
Degrees, certifications, and relevant coursework
Mangalore University - St. Aloysius College
Master of Science, Chemistry
2015 - 2017
Grade: 7.11
Activities and societies: Presented research at international and national conferences; won best paper award at Green Chemistry & Nanotechnology 2017.
Completed a Master of Science program at St. Aloysius College, Mangalore focusing on chemistry-related coursework and research.
Mangalore University - Alva's College, Moodbidri
Bachelor of Science, Chemistry
2012 - 2015
Grade: 8.21
Activities and societies: Internship as technical trainee in Biocon QC (Sep 2017–Mar 2018); conference presentations on phytochemicals and bioactive compounds.
Completed an undergraduate program with coursework in chemistry and related laboratory training.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
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