MOHAN KUMAR S
Bengaluru
Summary
ith over six years of experience in R&D and QC, specializing in Analytical method development, Validation, troubleshooting and comprehensive data review. Professional with a strong focus on quality, compliance and operational efficiency. Highly Motivated, detail-oriented and committed to supporting business growth in regulated environments.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Senior Research Associate
Kemwell Biopharma
02.2023 - Current
- Worked mainly on the Characterization of mAbs in the ADL.
- responsible for Method development, Method Qualification of LC and MS techniques & routine Process Developmental sample analysis in ADL.
- Involved in Scheduled Calibration & Performance Verification activity of HPLC, UHPLC & UPLC Instruments.
- Performed Empower audit trail reviews and periodic data backup & verification.
- Ensured compliance with GLP, GAMP5, 21 CFR Part 11, and ALCOA++standards
- Planned and Involved in Biosimilarity and Analytical Similarity assessment, Formulation Screening & stability studies.
- Authored critical quality documents such as MD, MQ and transfer protocols & its reports.
- Established workflows for PS80 Content Estimation, Pepmap by HPLC, Intrinsic fluorescence , Intact & Subunit Mass and AA Sequencing by LCMS.
- Trained and supervised junior Associates in laboratory protocols.
Research Associate
Kemwell Biopharma
02.2023 - 04.2025
Executive
Syngene International Limited
09.2021 - 02.2023
- Carried out Protein A HPLC, SEC, by UPLC, CEX, Peptide mapping & N-Glycan by UPLC, rProA, Protein Estimation by SoloVPE & UV Spectromentry analysis for method transfer, Validation and Inprocess batch support.
- Trained and proficient in handling laboratory instruments like Agilent HPLC 12XX series, Waters Acquity UPLC, UV Spectrophotometer, SoloVPE, Osmomat and other basic laboratory instruments.
- Familiar with GLP, cGMP, GDP, ALCOA+ and 21CFR part 11 compliance.
- Involved in technical troubleshooting and root cause investigations for Discrepancy, LIR and helped to implement corrective and preventive actions.
- Coordinated and worked with cross functional teams and other departments for method transfer and validation activities.
- Authored and reviewed STP & documents such as MT, MV protocols and their reports.
- Familiar with laboratory software tools such as EDMS & LIMS for advancement and smooth functioning of Quality control.
- Followed EHSS and general laboratory safety requirements in the workplace for ensuring individual and laboratory safety.
Junior Executive
Biogenomics Limited
10.2019 - 09.2021
- Trained molecules: Recombinant Trypsin, Recombinant Carboxypeptidase - B and Insulin analogues.
- Performed quality analysis and Documentation of In-Process, finished and stability samples with pharmacopeial standards.
- Handled and operated UV Spectrophotometer, HPLC, Multimode microplate reader, SDS - PAGE apparatus, TOC Analyzer, Gel Documentation system and other basic instruments.
- Chemical Analysis of Water (Raw, RO, DM, Purified and WFI) and Rinse samples.
- Revision of Standard Operating Procedures and Standard Testing Procedures Protocols.
Education
Biotechnology
K.S.Rangasamy College of Technology
Tiruchengode, Tamilnadu04.2019
Skills
- Recombinant Protein Characterization & Biosimilars Development
- LCMS - UPLC - UHPLC – HPLC
- Chromatographic Techniques (Protein A, PS80/PS20 content by CAD, RP, IEX, SEC, Peptide Mapping, N-Glycan content by HILIC)
- Empower 381 - Chromeleon 72 - XCalibar - Biopharma Finder - Softmax pro (65 & 71) - Labware LIMS - MS Office - SoloVPE
- GLP-GDP-ALCOA
- Periodic Data Backup & Review - Protocol & Reports review - Technical Troubleshoot - QMS
- Impurity Quantification assay (HCD, HCP, LPA, rProA) - Protein Estimation and Quantification Assays (UV @280nm, Bradford)
Certification
- Completed Online Certification Course conducted by NPTEL, IIT Madras. Titled “Applied Environmental Microbiology” (2018-01 – 2018-04).
- Completed certification courses on Diploma in Computer Application (DCA).
LANGUAGES:
Tamil (Native language); English (Full Professional Proficiency)
Disclaimer
I hereby declare that the Information contained herein is true and correct to the best of my Knowledge and belief. Bangalore.
Timeline
Senior Research Associate
Kemwell Biopharma
02.2023 - Current
Research Associate
Kemwell Biopharma
02.2023 - 04.2025
Executive
Syngene International Limited
09.2021 - 02.2023
Junior Executive
Biogenomics Limited
10.2019 - 09.2021
Biotechnology
K.S.Rangasamy College of Technology
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