Overview Goldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to high-level subject matter experts. Research and data driven, Goldbelt Professional Services’ experts create solutions customized to the client’s needs. Summary: Thisposition serves as the Bioengineer IV for JPM CBRN Task Order 3 contract in the DX Program Office. The Bioengineer IV shall provide technical, scientific, and programmatic support to the program office and project teams, providing advice and assistance for advanced development efforts (i.e., clinical, non-clinical, and manufacturing) related to medical diagnostics for CBR threats. Responsibilities Essential Job Functions: The contractor shall understand the diagnostic development process. The contractor shall understand the FDA review process and key dependencies between clinical science and the regulatory process. The contractor shall research and review scientific literature and databases to identify technical information and provide references to support product development efforts. The contractor shall conduct data analyses and create and submit study results for use in market research or publications. The contractor shall provide program office support and participation at conferences and stakeholder meetings. The contractor shall actively participate in internal and external IPTs, to include organizing meetings, preparing agendas, and documenting meeting minutes and action items. The contractor shall develop and/or review technical documentation. The contractor shall review scientific data, reports, and technical submissions from both government and non-governmental entities. The contractor shall draft and manage finalization of documents to include executive summaries, significant actions, manuscripts, and other technical documents (e.g., technology transition agreements, concept transition agreements, requests for proposals, statements of work, etc.). The contractor shall effectively communicate the results of assigned tasks and efforts, both orally and in written form, in a clear and concise manner, to include executive summaries, meeting presentations, documentation, technical and scientific reports and briefs. The contractor shall deliver written work products no later than the assigned suspense, which will be earlier than those established by external sources (e.g., SASI, DSS, higher headquarters suspense dates, etc.) to allow for Government review, revision, and coordination prior to Government approval and submission. The contractor shall participate in Technical Advisory Panels and interface with the Technical Review Advisory Board to assist in Technology Readiness Assessments. The contractor shall provide S&T oversight on availability, technology maturity, and applicability of proposed candidate CBRN medical countermeasures through advanced development, production, and fielding. 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 assist the PMs in assessing risks and developing mitigation strategies. 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. Qualifications Necessary Skills and Knowledge: Shall possess expertise in scientific and technical support of program management, product development, acquisition program strategic planning, contract guidance, oversight, and advisory services. Shall possess a strong understanding of relevant literature and be able to effectively debate highly technical issues with other contractors. Shall possess a working proficiency with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word. Shall possess strong analytical and problem-solving skills, as well as good organization skills to balance and prioritize work. Shall possess extensive customer support/relations experience. Shall possess strong interpersonal and communication skills, both oral and written. Shall be capable of maintaining interpersonal contacts to increase effective team dynamics and engagements with industry; effectively communicating ideas, requirements, and scientific knowledge across and within organizations united for the development of medical countermeasures. Minimum Qualifications: Master’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as ten (10) years of general experience and six (6) years of relevant experience. Tradeoff Requirement: The contractor shall possess a Bachelor’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as twelve (12) years of general experience and eight (8) years of relevant experience. Minimum six (6) years of experience in medical diagnostics and in vitro diagnostic development (IVD to FDA review) (*preferred*) or six (6) years of Industry experience in pharmaceutical/biotechnology advanced development (IND to FDA review). The contractor shall demonstrate medical diagnostic or pharmaceutical experience by providing evidence of patents achieved or multiple publications authored in peer-reviewed journals. Possess either experience in pre-clinical and clinical activities within assay and/or medical diagnostics advanced development (pre-submission to FDA review) or a background serving as a technical lead with specific experience writing and reviewing multiple pre-submission applications and 510(k) submissions, as well as an understanding of CLIA regulations and clinical laboratory test system complexity designations, clinical trial protocols, regulatory submissions, and technical reports. Clearance: Secret Minimum Qualifications: DAU Level II equivalency in Program Management or senior level experience in pharmaceutical/biotechnology drug development portfolio management (i.e., investment decisions based on the risk management process) is desired. DAU courses will be at Government cost; however, travel costs (ex: Per Diem, lodging, mileage) will not be at Government cost. Certification in Program Management (such as from the Program Management Institute) is desired and will be at no cost to the Government. Regulatory Affairs certification is desired and will be at no cost to the Government. Project Scheduling Professional certification is desired and will be at no cost to the Government. Sufficient experience in the use of Microsoft Project and Microsoft Excel to provide a level of proficiency that allows independent development and management of resource loaded IMSs and financial documents is desired. Drug-delivery device combination product experience. Pay and Benefits The salary range for this position is $120,000 to $155,000 annually. At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.