Reema Puri
- Role
- Principal Research Scientist, Formulations at Orchestra BioMed
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Reema Puri
A passionate and driven CMC development leader with over 15 years of experience…
Experience
Principal Research Scientist, Formulations
Sep 2021 — Present
Design and oversee pre-formulation, formulation development, process development/optimization, scale-up and clinical manufacturing activities for complex extended release formulations/combination products. • Leading formulation development/process optimization of a patented drug/device combination product used in the treatment of coronary angioplasty.(balloon). • Developed a dissolution method for sustained release drug delivery system using USP compendial apparatus IV (SOTAX). • Authored/reviewed various CMC documents such as product development reports, tech transfer reports, drug product specifications etc. • Authored/reviewed various design control related documents such as risk management plan, HAL, uFMEA, dFMEA, pFMEA and DHF.
Skills
- Nanotechnology
- Opthalmics
- Complex Sterile Injectables Formulation Development
- Particle Size Analysis
- Microfluidizer
- Combination Products - Pen Injectors , Pre-Filled Syringes
- High-Performance Liquid Chromatography (Hplc)
- Pre-Formulation/Formulation Development
- Osmometer
- 505b(2) Filing
- Dissolution Apparatus
- Anda Submission
- Design Control of Drug-Device Combination Products
- Lyophillization
- Cell Culture
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