Boris Gites
Managing Director at VeV Scientific, Inc.
- Role
- Managing Director at Vev Scientific, Inc
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Boris Gites
An individual who is always on the lookout for exciting opportunities in the biotechnology and pharmaceutical spaces. He is a professional with a strong graduate level academic foundation and extensive experience in research, development, manufacturing, quality assurance and regulatory.Specialties: Contract Manufacturing, Packaging, Quality Assurance, FDA, Regulatory
Experience
Managing Director
Apr 2014 — Present
Researched and selected key vendors to install software to comply with the Drug Supply Chain Security Act (DSCSA) of 2013; initiated complex reform of labeling procedures for adapting new compliant software.• Developed novel formulations for existing products, created and validated new manufacturing processes.• Installed a brand-new quality system for cGMP compliance for manufacturing commercial prescription pharmaceuticals.• Edited and implemented validation protocols for facility, processes and equipment necessary to ensure 21 CFR 211 compliance prior to beginning of commercial production.• Obtained DEA license, Drug Manufacturing License from California Department of Public Health, Registered facility with FDA and manufactured commercially available products for human consumption within five (5) months.
Education
Keck Graduate Institute of Applied Life Sciences
MBS, Bioprocessing, Business of Bioscience
2009 — 2011
UC San Diego
BS, Bioengineering (Biotechnology)
2005 — 2009
Skills
- Bioprocessing
- Manufacturing
- Powerpoint
- Microsoft Excel
- Dna
- Dna Extraction
- Matlab
- Business Development
- Experimental Design
- Diagnostics
- After Effects
- Photoshop
- In Vivo
- Elisa
- Start-Ups
- Aseptic Technique
- Life Sciences
- Lifesciences
- Purification
- Molecular Biology
- Bioengineering
- Excel
- Biopharmaceuticals
- Orphan Drugs
- Biotechnology
- Protein Purification
- Mentoring
- Research
- Fermentation Technology
- Batch Records
- Protein Chemistry
- Commercialization
- Hardware Diagnostics
- Gmp
- Dreamweaver
- Technology Transfer
- Entrepreneurship
- Antibodies
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