Jim Embree
Semi-retired; some consulting
- Role
- Sme at Tunnell Government Services, Inc.
- Location
- Daytona Beach, FL, US
- LinkedIn followers
- 500 followers
About Jim Embree
Uniquely qualified and positioned Product – Value – Solutions-Driven Senior Executive in…
Experience
Sme
Tunnell Government Services, Inc.
Jan 2010 — Present · Washington, DC, US
I primarily support the efforts of CBRN, Flu and IED projects from BARDA’s MFE division (Manufacturing, Facilities, and Engineering) as a manufacturing SME (Subject Matter Expert), principally in the areas of biologic products as MCM, their development (process and methods), and manufacturing phases through commercialization or SNS delivery. I support(ed) BARDA\'a effort (2014 through 2015 and beyond) to provide therapeutics against the Ebola Virus and the West African outbreak. I serve as a technical advisor for the advanced development of cell-based, monoclonal and recombinant products for CBRN product development and manufacturing initiatives. I advise and comment on general scientific and technical matters for product development in downstream and upstream processing through formulation and final fill.
Education
Northeastern University
M.S.H.S., Molecular Biology and Bacterial Genetics
1980 — 1983
UMass, Amherst
Bachelor of Science (B.S.), Microbiology and Immunology
Skills
- Biologics
- Manufacturing
- Purchasing
- Pharmaceutical Manufacturing
- Materials
- Validation
- Staff Building
- Regulatory Affairs
- Lifesciences
- Clinical Trials
- Clinical Development
- Pharmaceutical Industry
- Fda
- Product Development
- Technology Transfer
- Gmp
- Characterization
- Logistics
- Biotechnology
- Quality System
- V&V
- Shipping
- Construction
- Biopharmaceuticals
- Due Diligence
- Project Management
- Medical Devices
- Reliability
- Vaccines
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