Harikumar Vegesana
Lansdale,PA
Summary
Analytical chemistry professional with 10+ years of pharmaceutical laboratory experience supporting analytical method development, optimization, validation, verification, transfer, stability studies, and product commercialization. Strong hands-on expertise in HPLC/UPLC and Empower 3, with additional experience in GC, GC-MS, FT-IR, UV/Vis, FT-NMR, Karl Fischer, dissolution, SEC, RPLC, capillary electrophoresis, and particle-size analysis. Experienced in assay, related substances/impurity testing, forced degradation, stability-indicating methods, method robustness, precision, accuracy, linearity, OOS investigations, and analytical troubleshooting. Proven ability to collaborate with Quality, Regulatory, R&D, clients, and external laboratories to resolve analytical issues and support successful method transfer and implementation. Experienced in SOP development/revision, analyst training and mentoring, scientific documentation, and cGMP-regulated laboratory operations. Demonstrated laboratory efficiency improvement through dissolution method optimization that reduced average analysis time by 30%. Ph.D. in Natural Products Chemistry with a strong foundation in pharmaceutical and analytical research.
Overview
23
23
years of professional experience
Work History
SENIOR SCIENTIST – ANALYTICAL DEVELOPMENT
Kelly Services Inc.
Fort Washington, PA
05.2022 - 03.2026
- Led analytical method development and optimization activities for OTC tablet and liquid oral pharmaceutical products, using HPLC/UPLC and Empower 3 from early-stage R&D through product commercialization.
- Developed and optimized analytical methods supporting assay, related substances/impurity testing, stability studies, and stability-indicating analytical evaluation.
- Performed ICH Q2 method validation activities, evaluating precision, accuracy, linearity, robustness, and other critical validation characteristics.
- Conducted forced degradation studies to evaluate degradation behavior, supporting stability-indicating method development and evaluation.
- Performed method verification and analytical method transfer activities, including the transfer of methods to external laboratories and evaluation of analytical performance across testing sites.
- Investigated OOS results and analytical method-related issues, applying systematic troubleshooting and scientific evaluation of analytical data.
- Developed and optimized dissolution methods, enhancing laboratory efficiency through reduced average analysis time.
- Collaborated with Quality, Regulatory, R&D, and external laboratory teams to support analytical development, troubleshooting, method transfer, and commercialization activities.
- Trained and mentored less-experienced analysts in analytical techniques, laboratory procedures, GMP practices, method execution, and analytical troubleshooting.
RESEARCH ASSOCIATE
Eminent Services Corp. (CDMO)
Frederick, MD
04.2019 - 04.2022
- Planned and executed stability testing activities for pharmaceutical products and evaluated analytical results to support product development and quality assessments.
- Performed analytical testing of pharmaceutical solid dosage formulations using UPLC/HPLC, UV/Vis, FT-IR, Karl Fischer, and dissolution techniques.
- Developed analytical methods using capillary electrophoresis and UV/Vis spectroscopy for allergen-related samples.
- Investigated analytical challenges, troubleshot methods, and optimized procedures to enhance method performance.
- Planned and executed analytical activities for multiple client projects, ensuring adherence to project timelines and client requirements.
- Communicated with clients regarding analytical activities, technical issues, testing requirements, and project-related laboratory activities.
- Supported preparation and review of client technical and FDA-related documentation.
- Managed receipt, storage, shipment, inventory, and disposal of clinical-trial pharmaceutical materials, ensuring compliance with established procedures.
LAB SCIENTIST
Sainnocare Pharmaceuticals
Perkasie, PA
10.2018 - 01.2019
- Developed and validated analytical methods for pharmaceutical formulations using HPLC.
- Revised standard operating procedures and laboratory documentation to ensure compliance and accuracy.
- Trained colleagues on analytical laboratory techniques, enhancing team competency and knowledge retention.
ANALYTICAL CHEMIST
High Performance Products and Engineering
Columbus, GA
01.2018 - 05.2018
- Developed analytical testing procedures for Dextran and Pullulan using HPLC/SEC, column chromatography, viscometry, FT-IR, and UV spectroscopy.
- Conducted analytical testing of raw materials and pharmaceutical materials to ensure quality and compliance.
- Developed and synthesized Dextran and Levan variations, supporting microbial fermentation processes and enhancing product development.
- Maintained SOPs and laboratory records, ensuring adherence to cGMP standards and facilitating regulatory compliance.
PHARMACY TECHNICIAN
St. Francis Hospital
Columbus, GA
09.2012 - 12.2017
- Prepared sterile intravenous medications and pharmaceutical products, ensuring compliance with safety requirements and established procedures to support patient care.
- Managed pharmaceutical inventory and controlled-substance documentation, coordinating with vendors and maintaining regulatory records to ensure operational efficiency.
SENIOR SCIENTIFIC OFFICER
SMS Pharmaceuticals
Hyderabad, Telangana
09.2003 - 08.2007
- Conducted research on semisynthesis of coenzyme Q10 from solanesol, leading to preparation of semisynthetic analogs of bioactive compounds for enhanced therapeutic applications.
- Developed processes for isolation and purification of bioactive molecules from natural products, improving yield and quality of final products.
- Performed HPLC analysis and structural characterization of pharmaceutical compounds using IR, MS, and NMR techniques.
- Developed and formulated nutraceutical products at industrial scale, ensuring compliance with regulatory standards and meeting market demands.
- Maintained scientific and cGMP documentation and supported preparation of FDA-related dossiers.
Education
Ph.D. - Natural Products Chemistry
Guru Nanak Dev University
Amritsar, Punjab, India01-2003
M.Pharm. - Medicinal & Pharmaceutical Chemistry
Devi Ahilya Vishwavidyalaya
Indore, India01-1996
Skills
- Analytical Method Development & Optimization
- Analytical Development & Validation
- ICH Q2 validation
- Method verification
- Stability-Indicating Methods
- Impurity testing
- Forced Degradation Studies
- Robustness, Precision, Accuracy & Linearity
- Dissolution Method Development
- OOS Investigations
- Instrumentation & Analytical Techniques
- HPLC / UPLC – Empower 3, SEC / RPLC
- Waters HPLC/UPLC – Classic & H-Class
- GC / GC-MS, FT-IR, UV/Vis Spectroscopy
- FT-NMR, KF, Column Chromatography
- SDS-PAGE
- Pharmaceutical operations
- CGMP, ICH Guidelines
- SOP development
- Documentation management
- LIMS / ELN
- Instrument Maintenance
- Data interpretation
- Analytical problem solving
- Efficiency improvement
- Process improvement
- Project management
- Leadership & Collaboration
- Cross-functional teamwork
- Client communication
- External communication
- Analyst mentoring
- Report writing
- Problem solving
- Client communication
Timeline
SENIOR SCIENTIST – ANALYTICAL DEVELOPMENT
Kelly Services Inc.
05.2022 - 03.2026
RESEARCH ASSOCIATE
Eminent Services Corp. (CDMO)
04.2019 - 04.2022
LAB SCIENTIST
Sainnocare Pharmaceuticals
10.2018 - 01.2019
ANALYTICAL CHEMIST
High Performance Products and Engineering
01.2018 - 05.2018
PHARMACY TECHNICIAN
St. Francis Hospital
09.2012 - 12.2017
SENIOR SCIENTIFIC OFFICER
SMS Pharmaceuticals
09.2003 - 08.2007
Ph.D. - Natural Products Chemistry
Guru Nanak Dev University
M.Pharm. - Medicinal & Pharmaceutical Chemistry
Devi Ahilya Vishwavidyalaya