Assistant Vaccine Manager
Joint Vaccine Acquisition Program (JVAP)
The Tauri Group
Ft. Detrick, MD
Must have active Secret Clearance.
The Tauri Group, an innovator in analytical consulting, applies creative, responsive problem solving to homeland security, defense, and space enterprises. Government agencies and multinational contractors trust our objectivity and vision. They know we bring the leading minds in homeland security, technology, aerospace, arms control, public health, and more to tackle issues with no easy answers. Our projects are at the forefront of today's world of security, defense, science, and technology.
We are search for an Assistant Vaccine Manager to support the he Chemical and Biological Medical Systems (CBMS)-Joint Vaccine Acquisition Program (JVAP) which develops, produces, and stockpiles U.S. Food and Drug Administration (FDA)–licensed vaccine systems to protect the Warfighter against biological agents. The CBMS-JVAP consolidates the Department of Defense (DoD)'s efforts for advanced development, testing, FDA licensing, production, and storage of biological defense vaccines. The Assistant Vaccine Manager will work with vaccines especially plague or filovirus (Ebola/Marburg).
The Assistant Vaccine Manager will work to develop, produce, and stockpile U.S. Food and Drug Administration (FDA)–licensed vaccine systems to protect the Warfighter against biological warfare agents. JVAP consolidates the Department of Defense's efforts for the advanced development, testing, FDA licensing, production, and storage of biological defense vaccines.
The Assistant Vaccine Manager will:
• assist the vaccine manager on project teams, supporting risk planning efforts and providing advice and assistance in implementing process improvements for advanced development efforts (i.e., clinical, non-clinical, and manufacturing).
• assist the vaccine manager on internal and external Integrated Process Teams, responsible for organizing meetings, preparing agendas, documenting meeting minutes and action items, etc.
• assist the vaccine manager in maintaining program documents and staffing documents through the organization
• participate in contractor site visits, assisting in monitoring performance and quality standards, and providing technical oversight during study execution.
• provide scientific/technology advice, technical oversight, and project management support in the areas of science and technology availability, technology maturity, and applicability of proposed candidate CBRN medical countermeasures through advanced development, production, and fielding.
• collaborate with project teams and participate in the evaluation of technical results in multiple developmental areas, developing strategies to move the program forward.
• collaborate with both internal and external partners, contributing to data analyses in order to create and submit study results to publications or the FDA.
• conduct literature research projects to produce effective solutions for maintaining cost, schedule, and performance parameters.
• provide periodic update reports to program managers.
• assist the program managers in assessing schedule risks and developing mitigation strategies.
• provide technical input to acquisition documentation and presentations in support of major milestones, program reviews, or other program presentations.
• develop drafts and/or review and provide edits/comments to technical documentation (i.e., development/technology transfer reports, batch records, standard operating procedures, and regulatory submissions).
• author, edit, and contribute in the development of robust product development plans to support FDA approval under the Animal Rule.
• prepare and/or review draft protocols and study plans pertaining to a range of developmental efforts (i.e., manufacturing, non-clinical, clinical, and assay development), providing feedback in support of advanced development efforts.
• These activities will include collaboration with both internal and external partners.
• develop drafts and assist the project team to coordinate responsibilities, oversee quality management, and encourage timeliness of completion of protocols, IND applications, other regulatory submissions, and technical reports.
• assist in the preparation of documentation/presentations to summarize technical results, to include displaying results in “Layman’s” terms, formulating conclusions, and developing technical strategies in response to the data outcomes.
• maintain current knowledge on new technologies and methodologies that may benefit the program, assessing technical proposals critically and effectively, providing written technical opinion on the feasibility of new technologies, and organizing brown bag seminars to allow the product offices to review the technologies.
• review and search scientific literature and databases in order to identify technical information and to provide references to support product development efforts.
• be well organized, self motivator, excellent written and oral communication skills, adaptable to quick pace and changing priorities.
Must possess a Master’s degree in Biology, Biochemistry, Microbiology, Biochemical Engineering, or Pharmacology -AND- 5+ years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval) or must have Bachelors degree with + 15 years experience.
The Tauri Group offers competitive salary and benefits package including 401(k) with employer match, medical, dental, and vision insurance. EEO employer. To find out more about use please visit our website at: www.TauriGroup.com
To apply, please forward your resume along with a cover letter outlining your experience and salary expectations to: Debbie.Dyke@TauriGroup.com