Yogesh Bhonde
Saswad
Summary
Quality control professional with 5+ years of biopharmaceutical industry experience in biochemical, molecular, and analytical testing. Expertise includes HPLC/UPLC, ELISA, UV-Visible spectroscopy, SDS-PAGE, IEF, Western blot, bioassays, protein estimation, and N-glycan analysis. Conducts analytical method validation, computerized system validation (CSV), and manages incidents, deviations, and regulated documentation in GxP environments.
Overview
1
1
Certification
7
7
years of professional experience
Work History
Quality Control Executive / Quality Control Analyst
Gennova Biopharmaceuticals Ltd.
Pune, Maharashtra
11.2019 - Current
- Performed biochemical molecular and chemical analyses for pharmaceutical and biopharmaceutical products.
- Performed glucose and lactate testing by HPLC.
- Estimated protein concentration using UV-visible spectroscopy.
- Executed binding potency assays by ELISA for bevacizumab.
- Conducted bioassay testing for tenecteplase (TNK-TPA).
- SDS-PAGE, IEF gel electrophoresis, and western blot analyses.
- Maintained organisation under regulatory and internal compliance requirements.
- Performed N-glycan analysis by UPLC for bevacizumab.
- Analysed HMW aggregation and titre by HPLC for bevacizumab.
- Monomer estimation in TNK-tPA.
- Arginine analysis in the process of TNK-tPA.
- Supported HPLC calibration for Waters and Agilent systems.
- Worked with analytical instruments and computerised systems in regulated GxP.
- Validated analytical methods for protein content and potency assays.
- Performed CSV activities and implemented computerised systems in regulated settings.
- Investigated incidents and deviations with complete supporting documentation.
- Followed GxP/GLP SOPs, data integrity, and quality system requirements.
- Performed raw material sampling, testing, and pharmaceutical water analysis.
- Products handled.
- Bevacizumab.
- Tenecteplase (TNK-tPA).
- Erythropoietin.
Education
Integrated M.Sc./M.Tech. - Biotechnology
Institute of Bioinformatics and Biotechnology (IBB), Savitribai Phule Pune University
Pune, Maharashtra01.2019
Higher Secondary Certificate (HSC) -
Maharashtra State Board
Pune, MaharashtraSecondary School Certificate (SSC) -
Maharashtra State Board
Pune, MaharashtraSkills
- HPLC/UPLC - Agilent, Waters, and Thermofisher
- ELISA-Spectramax (SoftMax Pro)
- UV-visible spectroscopy (Shimadzu: LabSolutions)
- SDS–PAGE
- Western blot
- Bioassays (TNK-tPA)
- Protein estimation
- N-glycan analysis (bevacizumab)
- Analytical method validation
- Computerised System Validation (CSV)
- GxP computerised systems
- Incident and deviation management
- Data integrity
- Regulated laboratory practices
- HPLC calibration (Waters, Agilent, and Thermo Fisher)
- HPLC (Chromeleon 732, Empower 30)
Certification
Computerized System Validation (CSV) Certification
Additional Qualifications
- Maharashtra State Certificate in Information Technology, 2012-01-01
- Maharashtra State National Language (Hindi) Examination – Grade A/B
Custom Section
Pune, Maharashtra, India
Research
- Master's Thesis, Institute of Bioinformatics and Biotechnology, Savitribai Phule Pune University, Pune, Maharashtra, India, 2018-01-01, 2019-01-01, Comparative Genome-Wide Association Study of WRY, Dr. Tanushri Kaul
- Undergraduate Research Project, Pune, Maharashtra, India, 2016-01-01, 2017-01-01, Molecular Cloning and Characterization of Chalcone Synthase and Chalcone Isomerase Genes from the Medicinally Important Tree Oroxylum indicum, Dr. Vaijayanti A. Tamhane
Publications
De novo root transcriptome of medicinally important tree O. indicum for flavonoid biosynthesis pathway, Phytochemistry
Interests
Participated in Avishkar Competition, 2017, Savitribai Phule Pune University, Pune, Maharashtra, India
Hobbies and Interests
- Painting
- Cricket
- Chess
Timeline
Quality Control Executive / Quality Control Analyst
Gennova Biopharmaceuticals Ltd.
11.2019 - Current
Integrated M.Sc./M.Tech. - Biotechnology
Institute of Bioinformatics and Biotechnology (IBB), Savitribai Phule Pune University
Higher Secondary Certificate (HSC) -
Maharashtra State Board
Secondary School Certificate (SSC) -
Maharashtra State Board