Assistant Vaccine Manager

Organization
The Tauri Group
Job Location
Alexandria, VA
Salary
Neg
Benefits

The Tauri group provides its employees with competitive salaries and a rich benefits package including 401(k) with employer match and profit sharing.  We offer a collegial work environment and flexible work schedule.  EEO Employer

Job Description

JVAP Assistant Vaccine Manager Job Description

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Key requirements

  • Secret Clearance

  • Masters (Biology, Biochemistry, Microbiology, Biochemical Engineering, or Pharmacology) w 5+ years of Industry experience in pharmaceutical/biotechnology advanced development (alt Bachelors + 15).

  • Generally, work with vaccines preferred, especially plague or filovirus (Ebola/Marburg)

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Contractor support to the Department of Defense Joint Vaccine Acquisition Program (JVAP)

 

The Department of Defense’s Joint Vaccine Acquisition Program (JVAP) develops, produces, and stockpiles U.S. Food and Drug Administration (FDA)–licensed vaccine systems to protect the Warfighter against biological agents. The JVAP consolidates the DoD's efforts for advanced development, testing, FDA licensing, production, and storage of biological defense vaccines.           

 

The portfolio of fielded products includes the Anthrax Vaccine Adsorbed (AVA) Biothrax, the Smallpox Vaccine ACAM2000, and the Vaccinia Immune Globulin, a treatment for rare adverse reactions to the smallpox vaccine. The advanced development portfolio includes the plague vaccine, botulinum toxin vaccine, and filovirus vaccine.

 

 

Location:             Ft. Detrick, MD

Date Needed:     Immediate

 

Education and Experience Required

• Education: 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)

  • Alternate Education: Bachelor of Science degree in Biology, Biochemistry, Microbiology, Biochemical Engineering, or Pharmacology -AND- 15+ years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval)

    • Desired:  DAU Program Management Level II equivalency -OR- DoD experience in pharmaceutical/biotechnology vaccine and drug development portfolio management (i.e., investment decisions based on the risk management process)

    • 5+ years of working experience with Microsoft Office, to include MS Outlook, MS Project, MS PowerPoint, MS Excel, and MS Word

     

    Position Description

  •  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.

Requirements

Key requirements

  • Secret Clearance

  • Masters (Biology, Biochemistry, Microbiology, Biochemical Engineering, or Pharmacology) w 5+ years of Industry experience in pharmaceutical/biotechnology advanced development (alt Bachelors + 15).

  • Generally, work with vaccines preferred, especially plague or filovirus (Ebola/Marburg)

About Our Organization

The Tauri Group Space and Technology practice is looking for a driven candidate ready to build a career in the space industry and who is interested in the interface of technology, policy, and business. The Tauri Group applies deep knowledge in the space and satellite industry to the needs of government and commercial clients. We believe industry leaders require objective, data-driven analysis, free of vested interests and pre-conceptions, to make the right decisions. The Tauri Group cultivates a culture of engagement and partnership with our clients, whose success we take personally.

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