Ashok Subedi
Billerica,MA
Overview
11
11
years of professional experience
Work History
Scientist II
Stoke Therapeutics
12.2022 - Current
- Spearheaded the authoring of Investigational New Drug (IND) applications, ensuring compliance with regulatory requirements and facilitating successful submissions.
- Led technical transfer projects with Contract Research Organizations (CROs) to support clinical development, focusing on method development, validation, and transfer for HPLC analyses including Ion-Pair, HILIC, and Anion Exchange (AEX).
- Developed and optimized HPLC methods (Ion-Pair, HILIC, AEX) for the analysis of oligonucleotides and their conjugates, significantly improving assay robustness and sensitivity.
- Conducted comprehensive particulate matter analysis and buffer compatibility studies to support formulation development and ensure product stability.
- Implemented advanced LC-MS techniques for the characterization of oligonucleotides, contributing to the understanding of product purity and degradation pathways.
- Oversaw stability studies for drug substances and products, establishing stability-indicating methods and shelf-life estimations.
- Engaged in formulation development activities, assessing physical characteristics such as appearance, osmolality, and pH, to optimize drug product formulations.
- Acted as a Subject Matter Expert (SME) for analytical instruments, providing guidance on the operation and troubleshooting of LC-MS systems (Waters SQD2, Thermo Ion Trap), osmometers, and other analytical equipment.
Scientist
Moderna
08.2021 - 12.2022
- Developed advance analytical methodology for mRNA and lipid nanoparticles.
- Characterized mRNA higher-order structure using spectroscopic, calorimetric, and hydrodynamic techniques.
- Characterized lipid nanoparticle assembly, surface, and colloidal properties.
- Analyzed mRNA encapsulation state and lipid nanoparticle physical degradation pathways.
- Developed and applied particle sizing methodologies across the submicron, subvisible and visible size ranges
- Identify and evaluate opportunities for analytical innovation and improvement.
- Developed novel biophysical methodologies and drive technology innovation.
- Represent Biophysical team in cross-functional groups and translate project goals into actionable plans.
- Collaborate cross-functionally in the application of biophysical methodologies.
- Served as a subject matter expert for biophysical methods applied to product control and understanding.
SCIENTIST/ANALYTICAL DEVELOPMENT
Avanti Polar Lipids
08.2018 - 08.2021
- 1.Developed LC and mass spectrometry methods to characterize lipids, small molecule metabolites, and other biomolecules 2.Worked closely with other Technical Development teams to support raw material testing, process development, and degradant analysis
- 3.Updated and write standard operating procedure (SOPs) associated with production
- 4.Participated with project goals within the team and across the Technical
- Development dept
- 5.Worked as a GCMS, GC Headspace method development team lead
- 6.Developed SOLVID, Residual Solvent and FAME method, write SOP for 7.Developed HPLC purification and Identity method for lipid ingredient of
- COVID-19 vaccine
- 8.Developed laboratory testing programs and data analysis while adhering to SOPs, ECOs, batch records and work instructions.
Associate Scientist
Vega Pharmaceuticals
04.2013 - 01.2016
- Conducted comprehensive testing of drug substances, in-process samples, and drug products for small molecules, enhancing product quality and compliance.
- Developed and validated Karl Fischer titration methods for precise water content analysis, crucial for maintaining substance integrity.
- Spearheaded the development and validation of Gas Chromatography-Flame Ionization Detector (GC-FID) methods for solvent analysis, improving solvent control and product safety.
- Utilized High-Performance Liquid Chromatography (HPLC) for the release testing of drug substances and products, ensuring adherence to regulatory standards.
- Collaborated with cross-functional teams to support drug development processes, contributing to efficient and effective analytical strategies.
Education
Master of Science - Chemistry
University of Alabama At Birmingham
Birmingham, AL08.2018
Accomplishments
- 1 binds and negatively regulates the transcriptional function of tumorsuppressor p73MCL1 binds and negatively regulates the transcriptional functionof tumor suppressor p73cell death & disease
- Nov 3, 202
Timeline
Scientist II
Stoke Therapeutics
12.2022 - Current
Scientist
Moderna
08.2021 - 12.2022
SCIENTIST/ANALYTICAL DEVELOPMENT
Avanti Polar Lipids
08.2018 - 08.2021
Associate Scientist
Vega Pharmaceuticals
04.2013 - 01.2016
Master of Science - Chemistry
University of Alabama At Birmingham