Clearance Jobs
Bioengineer V
This position serves as the Bioengineer V for the JPM CBRN Task Order 3 contract in the Dx Program Office. The Bioengineer V shall provide technical, scientific, and programmatic support to the Dx 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. Essential Job Functions: Establish a link between clinical and non-clinical efficacy, developing a robust manufacturing strategy and defining product development schedules. Conduct data analyses and create and submit study results to use in market research or publications. Develop and/or review technical documentation. Provide program office support and participation at conferences and stakeholder meetings. Participate in internal and external IPTs, to include organizing meetings, preparing agendas, and documenting meeting minutes and action items. Draft reports, to include executive summaries, significant actions, manuscripts, and other technical documents. Research and review scientific literature and databases to identify technical information and provide references to support product development efforts. Review scientific data, reports, and technical submissions. Effectively communicate results of assigned tasks and efforts, both orally and in written form, in a clear and concise manner. Deliver written work products no later than the assigned suspense. Write reports and briefs. Review the reports and briefs of other agencies. Participate in Technical Advisory Panels and interface with the TRAB to assist in TRAs. Provide S&T oversight on availability, technology maturity, and applicability of proposed candidate CBRN medical countermeasures through advanced development, production, and fielding. Necessary Skills and Knowledge: Possess expertise in program management, product development, acquisition program strategic planning, contract guidance, oversight, and advisory services. Possess a strong understanding of relevant literature and be able to effectively debate highly technical issues with other contractors. Demonstrate experience with medical pharmaceutical products or diagnostic devices. 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: 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. Minimum ten (10) years of Industry experience in pharmaceutical/biotechnology advanced development (IND to FDA approval) or ten (10) years of experience in diagnostics and diagnostic development. Possess either experience in pre-clinical and clinical activities within assays and/or diagnostics advanced development (pre-submission to FDA licensure) 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-waived applications, clinical trial protocols, regulatory submissions, and technical reports. Clearance: Secret Preferred 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. Pay and Benefits: The salary range for this position is $130,000 to $175,000 annually. At Goldbelt, we provide 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.
This position serves as the Bioengineer V for the JPM CBRN Task Order 3 contract in the Dx Program Office. The Bioengineer V shall provide technical, scientific, and programmatic support to the Dx 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. Essential Job Functions: Establish a link between clinical and non-clinical efficacy, developing a robust manufacturing strategy and defining product development schedules. Conduct data analyses and create and submit study results to use in market research or publications. Develop and/or review technical documentation. Provide program office support and participation at conferences and stakeholder meetings. Participate in internal and external IPTs, to include organizing meetings, preparing agendas, and documenting meeting minutes and action items. Draft reports, to include executive summaries, significant actions, manuscripts, and other technical documents. Research and review scientific literature and databases to identify technical information and provide references to support product development efforts. Review scientific data, reports, and technical submissions. Effectively communicate results of assigned tasks and efforts, both orally and in written form, in a clear and concise manner. Deliver written work products no later than the assigned suspense. Write reports and briefs. Review the reports and briefs of other agencies. Participate in Technical Advisory Panels and interface with the TRAB to assist in TRAs. Provide S&T oversight on availability, technology maturity, and applicability of proposed candidate CBRN medical countermeasures through advanced development, production, and fielding. Necessary Skills and Knowledge: Possess expertise in program management, product development, acquisition program strategic planning, contract guidance, oversight, and advisory services. Possess a strong understanding of relevant literature and be able to effectively debate highly technical issues with other contractors. Demonstrate experience with medical pharmaceutical products or diagnostic devices. 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: 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. Minimum ten (10) years of Industry experience in pharmaceutical/biotechnology advanced development (IND to FDA approval) or ten (10) years of experience in diagnostics and diagnostic development. Possess either experience in pre-clinical and clinical activities within assays and/or diagnostics advanced development (pre-submission to FDA licensure) 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-waived applications, clinical trial protocols, regulatory submissions, and technical reports. Clearance: Secret Preferred 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. Pay and Benefits: The salary range for this position is $130,000 to $175,000 annually. At Goldbelt, we provide 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.