Kumara Swamy
@kumaraswamy
I lead pharmaceutical analytical R&D teams delivering API methods, impurity characterization, CDMO programs, and global regulatory support.
IndiaWhat I'm looking for
At Biocon, I lead a 12-member Analytical R&D team supporting synthetic, semi-synthetic, upstream/downstream, and peptide programs across three technical functions.
I deliver end-to-end analytical method development, validation, qualification, and inter/intra-lab transfer using HPLC, GC, LIMS, Chromeleon, and Empower. My work supports API regulatory filings for US, European, and Chinese markets aligned with USFDA, EMA, and ICH requirements.
I've led impurity isolation, purification, and structural characterization for small molecules, semi-synthetic products, and peptides, while managing CDMO analytical programs, customer communication, laboratory operations, CAPEX, and cross-functional delivery. I also lead OOS/OOT investigations through root-cause analysis, CAPA, and effectiveness checks.
At Biocon, I introduced a testing approach that generated approximately ₹2 Crore in annual savings and built in-house CDMO analytical capabilities that saved a further approximately ₹50 Lakh. I've also developed high-throughput HPLC methods that reduced analytical turnaround time by 25% and automated laboratory workflows to reduce manual data entry and transcription risk.
Experience
Work history, roles, and key accomplishments
Scientific Manager
Biocon Limited
Oct 2010 - Present (15 years 11 months)
Lead a 12-member Analytical R&D team across synthetic, semi-synthetic, upstream/downstream and peptide programs, driving scientific excellence and on-schedule project delivery. Implemented a new testing approach generating approximately ₹2 Crore in annual savings and developed high-throughput HPLC methods that cut analytical turnaround time by 25%.
Scientist
Aurigene Discovery Technologies Ltd.
Jan 2009 - Jan 2010 (1 year)
Executed GLP analytical studies and contract method validation for discovery samples and new APIs on behalf of Dr. Reddy's Discovery Research. Developed HPLC methods and performed preparative separation and impurity characterization.
Analytical / QC Professional
Apotex Pharmachem India (P) Ltd.
Jan 2005 - Jan 2009 (4 years)
Prepared and technically reviewed technology-transfer documentation; developed analytical methods and characterized impurities using HPLC, GC, particle-size analysis and DSC. Led partner-laboratory studies and method validation, and managed analytical equipment calibration and quality-status reporting.
Analytical / QC Professional
Cipla Ltd.
Jan 2003 - Jan 2005 (2 years)
Performed analysis of APIs, intermediates, raw materials and stability samples using laboratory analytical techniques. Calibrated and troubleshot HPLC, FTIR and KF titrator equipment while maintaining documentation in accordance with FDA, GMP, GLP and ISO requirements.
Education
Degrees, certifications, and relevant coursework
Jaipur University
Master of Business Administration, Supply Chain Management
MBA in Supply Chain Management from Jaipur University, completed in 2022.
Kuvempu University
Master of Science, Industrial Chemistry
Grade: First Rank, Gold Medalist
M.Sc. in Industrial Chemistry from Kuvempu University, completed in 2003, with First Rank and Gold Medal.
Availability
Location
IndiaAuthorized to work in
Job categories
Skills
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