Gary Vinson
Vice President, Chemistry & Manufacturing Controls (CMC) & Quality at NightHawk Biosciences, Inc- Claim this Profile
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Bio
Kristen D'Uva
I worked with Gary at BDSI. Our work together encompassed many aspects required to file a successful IND for the company in record time! Gary was easy to work with as well as promoting Quality work - I recommend him.
Janice Marie McCourt, BS, RPh, MBA, CLP
Gary and I were on the executive management team during my tenure at Heat Biologics (now NightHawk Bio). Gary is an experienced biotech operations executive with an excellent scientific understanding and strong technical leadership skills. Heat was a small company with limited funding. As functional leaders, we had to balance performing our roles while growing the business and product portfolio. Gary led all CMC operations, from R&D through to outsourcing of manufacture of clinical products, and he successfully completed filing several INDs to progress the pipeline for the company. Gary worked extremely well across functional groups to align efforts and actions, including with Business Development to support our efforts to secure licensing agreements with larger organizations. Gary was a pleasure to work with and I highly recommend him to any organization in an executive role leading CMC!
Kristen D'Uva
I worked with Gary at BDSI. Our work together encompassed many aspects required to file a successful IND for the company in record time! Gary was easy to work with as well as promoting Quality work - I recommend him.
Janice Marie McCourt, BS, RPh, MBA, CLP
Gary and I were on the executive management team during my tenure at Heat Biologics (now NightHawk Bio). Gary is an experienced biotech operations executive with an excellent scientific understanding and strong technical leadership skills. Heat was a small company with limited funding. As functional leaders, we had to balance performing our roles while growing the business and product portfolio. Gary led all CMC operations, from R&D through to outsourcing of manufacture of clinical products, and he successfully completed filing several INDs to progress the pipeline for the company. Gary worked extremely well across functional groups to align efforts and actions, including with Business Development to support our efforts to secure licensing agreements with larger organizations. Gary was a pleasure to work with and I highly recommend him to any organization in an executive role leading CMC!
Kristen D'Uva
I worked with Gary at BDSI. Our work together encompassed many aspects required to file a successful IND for the company in record time! Gary was easy to work with as well as promoting Quality work - I recommend him.
Janice Marie McCourt, BS, RPh, MBA, CLP
Gary and I were on the executive management team during my tenure at Heat Biologics (now NightHawk Bio). Gary is an experienced biotech operations executive with an excellent scientific understanding and strong technical leadership skills. Heat was a small company with limited funding. As functional leaders, we had to balance performing our roles while growing the business and product portfolio. Gary led all CMC operations, from R&D through to outsourcing of manufacture of clinical products, and he successfully completed filing several INDs to progress the pipeline for the company. Gary worked extremely well across functional groups to align efforts and actions, including with Business Development to support our efforts to secure licensing agreements with larger organizations. Gary was a pleasure to work with and I highly recommend him to any organization in an executive role leading CMC!
Kristen D'Uva
I worked with Gary at BDSI. Our work together encompassed many aspects required to file a successful IND for the company in record time! Gary was easy to work with as well as promoting Quality work - I recommend him.
Janice Marie McCourt, BS, RPh, MBA, CLP
Gary and I were on the executive management team during my tenure at Heat Biologics (now NightHawk Bio). Gary is an experienced biotech operations executive with an excellent scientific understanding and strong technical leadership skills. Heat was a small company with limited funding. As functional leaders, we had to balance performing our roles while growing the business and product portfolio. Gary led all CMC operations, from R&D through to outsourcing of manufacture of clinical products, and he successfully completed filing several INDs to progress the pipeline for the company. Gary worked extremely well across functional groups to align efforts and actions, including with Business Development to support our efforts to secure licensing agreements with larger organizations. Gary was a pleasure to work with and I highly recommend him to any organization in an executive role leading CMC!
Credentials
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Certified Pharmaceutical GMP Professional (CPGP)
ASQ - World Headquarters -
Regulatory Affairs Certification (RAC)
Regulatory Affairs Professionals Society (RAPS)
Experience
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NightHawk Biosciences, Inc
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United States
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Biotechnology Research
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1 - 100 Employee
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Vice President, Chemistry & Manufacturing Controls (CMC) & Quality
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Oct 2017 - Present
NightHawk Biosciences, Inc. is a public, clinical-stage biotechnology company focused on development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient's own immune system to eradicate cancer cells. NightHawk Biosciences, Inc. is a public, clinical-stage biotechnology company focused on development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient's own immune system to eradicate cancer cells.
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BioDelivery Sciences International
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Vice President, Pharmaceutical Development
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Aug 2016 - Jul 2017
BioDelivery Sciences is a specialty pharmaceutical company with a focus in the areas of pain management and addiction medicines. BioDelivery Sciences is a specialty pharmaceutical company with a focus in the areas of pain management and addiction medicines.
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The Perdoceo Group
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Raleigh-Durham, North Carolina Area
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Managing Partner
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Jan 2011 - Aug 2016
The Perdoceo Group, LLC provided management consulting services to the pharma/biotech industries; specializing in support of cGMP product and manufacturing/process development for clinical and commercial stage companies, developing/optimizing supply chain stratgies & developing regulatory strategy for CMC development/compiling filings to FDA . The Perdoceo Group, LLC provided management consulting services to the pharma/biotech industries; specializing in support of cGMP product and manufacturing/process development for clinical and commercial stage companies, developing/optimizing supply chain stratgies & developing regulatory strategy for CMC development/compiling filings to FDA .
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Aldagen, Inc
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Biotechnology Research
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1 - 100 Employee
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Vice President, Manufacturing & Product Quality
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Feb 2004 - Oct 2010
Aldagen was a clinical-stage biopharmaceutical company developing regenerative medicine therapies using adult stem cells. The company had two key clinical programs; adult stem cells harvested from bone marrow used as therapy for ischemic heart failure/stroke and critical limb ischemia (peripheral artery disease) and adult stem cells harvested from donor cord blood units used to aid success of cord blood transplants in children with metabolic disorders. Aldagen was a clinical-stage biopharmaceutical company developing regenerative medicine therapies using adult stem cells. The company had two key clinical programs; adult stem cells harvested from bone marrow used as therapy for ischemic heart failure/stroke and critical limb ischemia (peripheral artery disease) and adult stem cells harvested from donor cord blood units used to aid success of cord blood transplants in children with metabolic disorders.
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Cardinal Health
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United States
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Hospitals and Health Care
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700 & Above Employee
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Director, Quality Assurance
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1998 - 2004
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GSK
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Manager, Product Outsourcing
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1986 - 1998
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Education
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North Carolina State University
Bachelor of Science - BS, Chemistry
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