Kishore Aluguvelli

About Kishore Aluguvelli

Experienced Analytical professional with expertise in method development, validation, and transfer for a diverse range of drug substances and formulations, including oral solids, oral liquids, topical products, ophthalmic formulations, and injectables (biologics and mRNA vaccines). Expertise in establishing analytical control strategies, phase-appropriate quality specifications, and stability studies aligned with ICH guidelines. Extensive experience in regulatory submissions (IND, NDA, ANDA, BLA) and responding to regulatory inquiries. Skilled in managing analytical activities across internal and external laboratories (CMO, CDMO, CTO), ensuring seamless method transfers, regulatory compliance, and quality oversight. Proficient in a wide range of analytical techniques, troubleshooting, and laboratory management in cGMP/GLP environments. Strong leadership abilities in driving cross-functional collaboration, regulatory alignment, and operational efficiency.

Experience

1. Sr Scientist Sr Manager

   Moderna

   Apr 2024 — Present · Norwood, MA, US

   Lead analytical strategy for lipid and small molecule programs across all development stages, from early-phase research to post-commercialization, ensuring robust control strategies, specification development, comparability studies, method bridging, regulatory compliance, stability study design, and project timeline management- Undertake technical management for analytical testing to support multitude of activities in early to late phase development- Undertake technical management for analytical testing at external CRO/CMO- Create, track and manage technical deliverables and activities for project milestones- Build strong knowledge of synthetic chemistry for small molecules to support lipid projects- Scientifically evaluate needs of lipid project and create deliverables- Undertake very detail-oriented work to mine data, trend them, statistically evaluate them for assay performance and integrity of results- Contribute to strategy, review and management of qualification/validation protocols and reports utilizing ICH/Regulatory guidances from external CRO/CMOs- Work with various SMEs within the Analytical team to identify need for new method development, create deliverables, troubleshoot assays, track and manage them etc- Provide summary presentations and detailed reports to internal and external stake holders- Provide subject matter expertise to support major lipid projects- Generate high quality documentation to support regulatory filings be it brief or comprehensive technical protocols and reports, IND modules.

Education

• Western Illinois University

  Masters, Analytical Chemistry

  2009 — 2011

• Osmania University

  Bachelors, Pharmacy

  2005 — 2009

Skills

• Karl Fisher
• Gas Chromatography
• Gc/Ms
• Glp
• Lims
• Uv/Vis Spectroscopy
• Good Laboratory Practice (Glp)
• Atomic Absorption
• High-Performance Liquid Chromatography (Hplc)
• Particle Size Analysis
• Ftir
• Hplc
• Lc-Ms
• Particle Size Analyzer
• Uv-Vis
• Uv/Vis
• Gc-Ms
• Kf Titration
• Potentiometric Titration