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: The Bioengineer V for the JPM CBRN Task Order 3 contract in the CTO Program Office 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 assist with Government oversight of development contractor efforts, to include conducting site visits, assisting in monitoring performance and quality standards, and providing technical oversight during study execution. The contractor shall establish a link between clinical and non-clinical efficacy, developing a robust manufacturing strategy and defining product development schedules. The contractor shall conduct data analyses and create and submit study results to use in market research or publications. The contractor shall develop and/or review technical documentation. The contractor shall provide program office support and participation at conferences and stakeholder meetings. The contractor shall participate in internal and external IPTs, to include organizing meetings, preparing agendas, and documenting meeting minutes and action items. The contractor shall draft reports, 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 research and review scientific literature and databases to identify technical information and provide references to support product development efforts. The contractor shall review scientific data, reports, and technical submissions. The contractor shall effectively communicate 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, and reports. 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 will be required to write reports and briefs. The contractor will be required to review the reports and briefs of other agencies. Qualifications Necessary Skills and Knowledge: Shall possess expertise in 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. Proficiency with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word. Shall possess familiarity and expertise with all aspects of biologics current GMP (i.e., quality assurance, quality control, master cell bank production, working cell bank production validation, installation qualification, operating qualification, process qualification, engineering runs, process validation runs, consistency lot production, and biologics license application preparation). Shall demonstrate proficiency in current good laboratory procedures; FDA Animal Rule requirements, application procedures, and implementation; FDA requirements for IND and NDA submission, approvals, and licensure; preparation for and conduct of DA Type A, B, and C meetings; and FDA qualification of drug development tools. Minimum Qualifications: PhD in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience. Tradeoff Requirement: The contractor shall possess a Master’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as twenty (20) years of general experience and fifteen (15) years of relevant experience. Shall possess ten (10) years of Industry experience in the pharmaceutical/biotechnology industry focused on advanced development (IND to FDA approval). The contractor shall demonstrate pharmaceutical experience by providing evidence of multiple publications authored in peer-reviewed journals or demonstrated product development of antivirals, vaccines or chemical therapeutics to FDA approval. Shall possess experience aligning FDA processes with DoD acquisition requirements for the development and procurement of medical products and systems for biodefense, to include an understanding of regulations applying to bio-surety. Shall have experience in the design, installation, commissioning, and/or validation of Single Use Systems (SUSs). Clearance: Secret Pay and Benefits The salary range for this position is $130,000 to $175,000 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.