Amish Patel
Head of TechOps Amazon. Strategic Leader in Global Biologic Operations
- Role
- Head of Technical Operations Special Projects at Amazon
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Amish Patel
CMC: Vaccines, Biologics, Preclinical Research and Development, GMP, Phase I, Phase II, Phase Validation, Commercial manufacturing, Commercial sales team support, Medical affairs team support, Regulatory filing strategy, FDA, EMA, HC, SwissMedics. TGA and other regulatory agencies meetings and audits, Life cycle management, Tech Transfer, CMO, Small molecule, Large molecule, Adenovirus, Allogenic Stem Cells, Oncolytic virus, Virus like particle, DNA, Viral and Bacterial Formulation and Process Development, Delivery science, Fill finish powder and liquid, Vaccine storage, Vaccine supply chainLead cross functional teams to resolve complex project issues utilizing regulatory expertise to seek appropriate agency approvalsDesigned study to transfer technology from R&D to Production.Implementation of Quality Management Systems QMS for companies to meet GxP compliance ( GlP, GmP, GcP)Build CMC Team and lead functions: Research, Development, Process Development, Manufacturing, Assay/Analytical Development, Quality Control, Quality Assurance, Supply ChainStrategic PlanningPI on NIH grantNIH review panel
Experience
Head of Technical Operations Special Projects
Sep 2024 — Present · Seattle, WA, US
Amazon Strategic Initiative
Education
Louisiana Tech University
PhD, Engineering, Nanotechnology
2002 — 2004
Louisiana Tech University
M.S., Chemical, Nanotechnology
2000 — 2002
Pune University
B E, Chemical
1995 — 1999
Skills
- Regulatory Submissions
- Contract Manufacturing
- Drug Delivery
- Cell Biology
- Dna Encapsulation
- Sustained Release Profile
- Cmc
- Ind
- Aseptic Processing
- Formulation
- Pharmaceutics
- Drug Discovery
- Lyophilization
- Technology Transfer
- Nanotechnology
- Lifesciences
- R&D
- Life Sciences
- Science
- Biochemistry
- Clinical Development
- Pharmaceutical Industry
- Aseptic Technique
- Commercialization
- Process Development for Biologics
- Biotechnology
- Cell Encapsuation
- Layer by Layer Self Assembly
- Nanoparticles
- Vaccine
- Drug Development
- Oral Dosage Forms for Biologics
- Biopharmaceuticals
- Clinical Trials
- Gmp
- Virology
- Vaccines
- Nanofilms Fabrication
- Thin Films
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