Mahalingesh Tuppad
Athlone,Ireland
Summary
Results-driven Biopharma Research Scientist with 12+ years of experience in analytical method development, biopharmaceutical characterization, and regulatory compliance. Expertise in chromatography (HPLC, UPLC, LC-MS), electrophoresis (CE, icIEF) for monoclonal antibodies, recombinant proteins, and vaccines. Skilled in method validation (ICH Q2), stability studies, impurity profiling, and higher-order structure analysis. Strong background in cGMP/GLP environments, contributing to regulatory submissions and cross-functional collaboration in drug development. Passionate about advancing biopharma innovation through cutting-edge analytical techniques and data-driven decision-making.
Overview
12
12
years of professional experience
Work History
Associate Research Scientist
Thermo Fisher Scientific
Athlone, Westmeath
01.2023 - 03.2025
- Developed and validated LC and CE-based assays for impurity profiling and stability testing.
- Conducted forced degradation and stability studies per ICH guidelines.
- Developed and validated analytical methods for monoclonal antibodies and recombinant proteins.
- Authored technical reports, method validation protocols, and regulatory dossiers
- Worked in a cGMP/GLP-compliant laboratory and supported regulatory inspections.
- Investigated product impurities using mass spectrometry and capillary electrophoresis.
Analytical Scientist
Stelis Biopharma limited
Bengaluru, Karnataka
12.2019 - 12.2022
- Validated robust analytical methods (e.g., SEC, RP-HPLC, CE-SDS, cIEF) for the characterization and quality control of monoclonal antibodies
- Designed stability studies to assess degradation pathways and ensure product integrity under ICH guidelines
- Authored detailed technical reports and contributed to regulatory submissions
- Prepared and reviewed analytical testing records, including test protocols, and validation reports for quality-critical processes
- Maintained and reviewed Quality Records, including deviation reports, CAPAs, change control documentation, and laboratory investigation reports in accordance with cGMP standards
- Conducted root cause analysis for quality incidents and implemented corrective and preventive actions (CAPAs) to mitigate risks
- Addressed client inquiries and concerns during telecoms, proposing actionable solutions to maintain project alignment and satisfaction
Senior scientist
Anthem Biosciences private limited
Bengaluru, India
01.2016 - 11.2019
- Developed and validated analytical methods (e.g., HPLC, GC, CE, LCMS) for the quantification, impurity profiling, and characterization of pharmaceutical products
- Designed and executed forced degradation studies to evaluate the chemical and physical stability of drug substances under stress conditions
- Calibrated and maintained analytical instruments, including HPLC, GC, UV-Vis spectrophotometers, and FTIR, ensuring optimal performance and compliance with regulatory standards
- Performed instrument qualification (IQ, OQ, PQ) for laboratory equipment and validated associated software, ensuring alignment with GMP requirements
- Characterized biosimilar products, including aggregation analysis, glycosylation profiling, charge variant analysis, and potency assays, to confirm comparability with reference products
QC Chemist
Shiva Analyticals Private limited
Bengaluru, India
03.2015 - 12.2015
- Conducted analytical method validation and method transfer for various instruments, including HPLC, GC, LC-MS, and GC-MS, ensuring reliability and compliance with regulatory standards
- Prepared detailed analytical protocols and comprehensive reports to document experimental methods, results, and conclusions
- Performed working standard qualification, ensuring the accuracy, stability, and suitability of standards for routine analysis
- Reviewed analytical data for precision, accuracy, and compliance with predefined specifications, ensuring data integrity and regulatory adherence
- Testing samples using various analytical instruments like HPLC, UPLC, GC, KF autotitrator, FTIR, UV spectroscopy, Polarimeter
- In-process support by analyzing samples using various analytical techniques
QC Executive
Biocon Limited
Bengaluru, India
01.2013 - 03.2015
- Expertise in analytical testing, regulatory compliance, and GMP-based quality assurance.
- Skilled in HPLC, GC, UV-Vis Spectroscopy and Dissolution Testing for raw materials, intermediates, and finished products.
- Strong understanding of cGMP, GLP, ICH, USFDA, MHRA guidelines, and documentation for regulatory audits.
Education
Master of Science - Chromatography, Spectroscopy, stoichiometry, organic chemistry, polymer chemistry
Kuvempu university
India 06/2010 - 05/2012
Bachelor of Science - Chemistry, Botany & Zoology
Tumkur University
India 06/2007 - 05/2010
Skills
Project Management & Communication:
Analytical Techniques:
- Chromatography: HPLC, UPLC, SEC, RP-HPLC, IEX, HIC
- Mass Spectrometry: LC-MS
- Electrophoresis: CE-SDS, icIEF, Gel Electrophoresis
Biopharma
- Characterization of monoclonal antibodies (mAbs), recombinant proteins, gene therapy products, and vaccines
- Method Development & Validation (ICH Q2 guidelines)
- Forced degradation & stability studies
- Impurity profiling & comparability studies
Regulatory & Compliance:
- cGMP, GLP, ICH, USP/EP regulatory standards
- IND, BLA, and regulatory submission support
Data Analysis & Software:
- Empower, Chromeleon, Lab solutions, Chem station, Mass hunter
- Technical report writing, SOP development, regulatory documentation
- Cross-functional collaboration with R&D, QA/QC, and regulatory teams
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Personal Information
- Date of birth: 07/30/88
- Nationality: INDIAN
Languages
English
Fluent
Timeline
Associate Research Scientist
Thermo Fisher Scientific
01.2023 - 03.2025
Analytical Scientist
Stelis Biopharma limited
12.2019 - 12.2022
Senior scientist
Anthem Biosciences private limited
01.2016 - 11.2019
QC Chemist
Shiva Analyticals Private limited
03.2015 - 12.2015
QC Executive
Biocon Limited
01.2013 - 03.2015
Master of Science - Chromatography, Spectroscopy, stoichiometry, organic chemistry, polymer chemistry
Kuvempu university
06/2010 - 05/2012
Bachelor of Science - Chemistry, Botany & Zoology
Tumkur University
06/2007 - 05/2010
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