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Posted by: The Tauri Group on Mar 20, 2018


Location:

Frederick , MD 21702

Job Description:

Established in 2001, The Tauri Group is a professional services firm known for our analytic rigor, practical solutions, and trusted advice in the areas of CBRN threat mitigation, defense science and technology, homeland security, and adjacent domains. We offer the financial stability and breadth of capability of a large company coupled with the corporate commitment and attention of a small firm. Our subject matter expertise, determination, agility, and commitment to active and ongoing client and stakeholder engagement enable us to solve tough problems and deliver results-oriented solutions that help our customers achieve mission success. We tackle our clients' most challenging problems by combining analytical rigor with world-class expertise and relevant operational experience. At The Tauri Group, we do what's right for the Program, the Mission, and the Nation.

We are seeking a lead scientist who understands the drug development/FDA processes to support the JPEO-CBD JPM Medical Countermeasures Systems, Joint Vaccine Acquisition Program (JVAP) at Ft Detrick MD.

Candidates must have a current SECRET clearance

Education and Experience Required
Standard Requirement: The contractor shall possess a Master's degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as eight (8) years of general experience and five (5) years of relevant experience. Alternate/Tradeoff Requirement: The contractor shall possess a Bachelor's degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as ten (10) years of general experience and seven (7) years of relevant experience. Additional Education: The contractor shall possess DAU Level I equivalency in Program Management or senior-level DoD experience in pharmaceutical/biotechnology vaccine and drug development portfolio management (i.e., investment decisions based on the risk management process). The contractor shall possess five (5) years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval). The contractor shall possess five (5) years of project management experience in cost, schedule, performance, risk analysis, and advice. The contractor shall possess DoD experience in pharmaceutical/biotechnology vaccine and drug development portfolio management (i.e., investment decisions based on the risk management process). The contractor shall possess strong analytical and problem solving skills, as well as good organization skills to balance and prioritize work. The contractor shall possess extensive customer support/relations experience. The contractor shall possess strong interpersonal and communication skills, both oral and written. The contractor shall be capable of maintaining interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge across and within organizations united for the development of medical countermeasures. The contractor shall possess five years of working experience with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word. Desired: The contractor may possess DAU Level II certification, or its civilian equivalency, in Program Management or senior level DoD experience in pharmaceutical/biotechnology vaccine and drug development portfolio management (i.e., investment decisions based on the risk management process).
Performance Based Tasks Required
The contractor shall serve as the technical representative 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). The contractor shall serve on internal and external IPTs, responsible for organizing meetings, preparing agendas, documenting meeting minutes and action items, and maintaining the document archive system. The contractor shall provide written technical opinions to guide the decision-making process of the IPT. The contractor shall participate in contractor site visits, assisting in monitoring performance, regulatory and quality standards, and providing technical oversight during study execution. The contractor shall serve as the programmatic representative at conferences and stakeholder meetings. The contractor shall 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, DoD acquisition processes, production, and fielding. The contractor shall provide technical knowledge to guide the product team in establishing a link between clinical and non-clinical efficacy, developing a robust manufacturing strategy, and defining product development schedules. The contractor shall collaborate with project teams and participate in the evaluation of technical results in multiple developmental areas, developing strategies to move the program forward. The contractor shall collaborate with both internal and external partners, contributing to data analyses in order to create and submit study results to publications or the FDA. The contractor shall collaborate with internal and external partners and research projects to produce effective solutions for maintaining cost, schedule, and performance parameters. The contractor shall provide periodic update reports to PMs. The contractor shall assist the PMs in assessing cost and schedule risks and developing mitigation strategies. The contractor shall draft and/or review acquisition documentation and presentations in support of major milestones, program reviews, or other program presentations. The contractor shall 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). The contractor shall author, edit, and contribute to the development of robust product development plans to support FDA approval under the Animal Rule. The contractor shall 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. The contractor shall develop drafts and assist the project team to coordinate responsibilities, oversee quality and regulatory management, and encourage timeliness of completion of protocols, IND applications, other regulatory submissions, and technical reports. The contractor shall prepare 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. The contractor shall 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 Joint Product Offices to review the technologies. The contractor shall review and search scientific literature and databases in order to identify technical information and to provide references to support product development efforts. The contractor shall assist to identify and assess risks of new technologies and ongoing projects. The contractor shall interface with the stakeholder community to ensure office coordination. The contractor shall prepare briefing materials. The contractor shall serve as the assistant vaccine manager on project teams, supporting risk planning efforts and providing advice and assistance in implementing technical reviews and process improvements for advanced development efforts (i.e., clinical, non-clinical, and manufacturing). The contractor shall support the Assistant PMs in developing program schedules, cost estimates, presentations, and other routine program management requirements. The contractor shall work as a self-starter, both independently and as part of a team, as deputy to the Assistant PM.
At The Tauri Group, you'll collaborate with an elite, creative team of scientists, engineers, analysts, operations specialists, policy experts, and acquisition support specialists. We attract people who love their work and are dedicated to the complex challenges facing today's world. Our culture fosters engagement and enthusiasm, attracts and retains proven experts, and maintains a flexible environment that supports clients and staff. From our easily accessible offices in Alexandria, Virginia to our comprehensive benefits package, every aspect of our operations is designed to bring us the best in the field.

Financially, The Tauri Group is a smart choice, offering:
Highly competitive salaries 401(k), including competitive matching and 100 % vesting after only one year Business development and referral bonuses
We support your life outside of the office, too, with benefits including:
Highly competitive medical insurance and multiple plans to choose from Dental and vision insurance plans Tuition assistance Professional development opportunities Eight paid hours a year that you can devote to charity Flexible work schedules
Accessibility: If you need an accommodation as part of the employment process please contact Human Resources at HR@taurigroup.com

Equal Opportunity Employer, including disabled and veterans.

Pay Rate:

Unspecified

HR. Website URL:

https://taurigroup.com/careers.html#opportunities

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About The Tauri Group,Inc.

The Tauri Group confronts national security challenges by creating innovative, multi-dimensional, and operationally relevant solutions. Decision-makers know they can rely on our expertise and judgment for comprehensive, defensible advice.

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