Harsha Chandrakant Lonkar
Pune
Summary
Dedicated, sincere and ambitious budding professional with excellent attention to detail, passion for learning new skills and developing research interest by working with experienced professionals. Having 3+ years of experience in Analytical method development, Method qualification and related quality assurance, compliance of GMP environment. Strong background in data collection, analysis, and interpretation. Skilled in utilizing advanced analytical methodologies to drive insightful research outcomes. Proven ability to manage multiple projects, collaborate with cross-functional teams, and deliver comprehensive reports that inform decision-making. Brings commitment to advancing scientific understanding and contributing to impactful research initiatives.
Overview
3
3
years of professional experience
Work History
Research Associate
CuraTeQ Biologics (Aurobindo Pharma)
Hyderabad
04.2025 - Current
- Developed methods for monoclonal antibody production using CIEF and ion exchange chromatography.
- Prepared documents including standard laboratory procedures, MQP, and development reports.
- Provided in-process support for USP and DSP departments through IEX, SEX, and glycan analysis.
Research Associate
Enzene Biosciences Limited
Pune
01.2022 - 04.2025
- Expertise in analytical method development for the analysis of biopharmaceutical molecules, ensuring identity and purity with accurate, reliable, and reproducible results.
- Experience in LC-based (IEX, SEC, RP) method development for monoclonal antibodies, growth factors, and small molecules.
- Experienced in method qualifications protocol preparation, planning and execution of analysis with compliance to regulatory guidelines (ICH Q2 R2) for method qualification and validation.
- Involved in technology transfers from R&D to quality control, involving technology transfer document preparation, and the demonstration/execution of methods for ensuring efficient and seamless integration of methods into quality control.
- Extensively supported in-process DSP, USP, and formulation studies for products, with timely analysis, interpretation, and communication of data across cross-functional teams.
- Performed batch release testing for DS and DP using analytical methods, like size exclusion and cation exchange chromatography-based methods, for purity analysis, and preparation of COA/ROA for release.
- · Performed timely stability testing, data analysis, trend preparation for stability of molecules.
- Worked on several CDMO projects with strict timelines, completing the analysis within the timeline, and documenting the results and raw data.
- Successfully performed forced degradation studies for mAbs, fusion protein molecules, and evaluated the degradation trends for global campaign prerequisites.
- Completed stability studies for DS, DP using HPLC, UPLC, and protein concentration detection techniques, and prepared sample stability reports.
- Performed biosimilarity of molecules using orthogonal techniques, like CD spectroscopy, CE SDS, and cIEF.
- Managed and maintained analytical instruments ensuring their proper functioning, calibration and qualification activities completion on timely basis, troubleshooting and resolving the issues with support of cross functional teams.
- Involved in inventory management and indenting activities for requirements of Claboratory materials (Chemicals, consumables stock management).
- Maintained good documentation practices and good laboratory practices on a daily basis during the documentation and execution of experiments.
Education
Msc - Biotechnology
Fergusson Autonomous University
Pune, IndiaBsc - Biotechnology
Fergusson Autonomous University
Pune, IndiaHSC -
Kendriya Vidyalaya Ganeshkhind
Pune, IndiaSSC -
Kendriya Vidyalaya Ganeshkhind
Pune, IndiaSkills
Instruments handled/Techniques:
- HPLC (SEC, IEX, RP HPLC)
- UPLC
- Synergy plate reader
- SoloVPE
- Circular dichroism spectroscopy and fluorescence spectroscopy
- Capillary isoelectric focusing
- CE-SDS
- Maurice system by Protein Simple (CE, SDS, and cIEF)
- Osmometer
- Agarose gel electrophoresis
- Laminar airflow and aseptic handling of cell lines
- Hematocytometer
- Via cell counter
- NanoDrop
Software's used:
- Empower
- Compass for ICE
- Gen5
- Cary WinUV
- Jasco Spectra Manager
- MS Office
- MS Word
- MS PowerPoint
- MS Excel
Projects
May 2021–October 2021: DBT-funded project under the guidance of Mrs. Nandini Kotharkar, faculty of Bioinformatics at Fergusson College, topic: investigation of anti-bacterial, anti-oxidant, and anti-arthritic activities of ethanolic extracts from the flowers of Nyctanthes arbor-tristis plant.
Exams Qualified
GATE- BT 2022
Languages
Marathi
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
References
References available upon request.
Timeline
Research Associate
CuraTeQ Biologics (Aurobindo Pharma)
04.2025 - Current
Research Associate
Enzene Biosciences Limited
01.2022 - 04.2025
Msc - Biotechnology
Fergusson Autonomous University
Bsc - Biotechnology
Fergusson Autonomous University
HSC -
Kendriya Vidyalaya Ganeshkhind
SSC -
Kendriya Vidyalaya Ganeshkhind
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