Project Manager - Scientist IV

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 Scientist IV shall serve as the technical representative/integrator 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). Responsibilities Essential Job Functions The contractor shall serve as the technical representative/integrator 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 as the technical/programmatic lead on internal and external IPTs, responsible for organizing meetings, preparing agendas, documenting meeting minutes and action items, etc. The contractor shall serve as the technical/programmatic point of contact, participating in contractor site visits, assisting in monitoring performance and quality standards, and providing technical oversight during study execution. The contractor shall serve as the technical representative at conferences and stakeholder meetings. The contractor shall provide scientific/technological advice as it pertains specifically to microbiology and/or immunology to the product teams within Accelerated Defense Pharmaceuticals, Biological Defense Pharmaceuticals, or Diagnostics as requested. The contractor shall provide scientific/technology advice, technical oversight, and acquisition support in the areas of science and technology availability, technology maturity, and applicability of proposed candidate CBRN prophylactic and therapeutic drugs, biologics, and devices through advanced development, 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 provide written technical opinions to guide the decision-making process of the IPT. 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 conduct research projects to produce effective solutions for maintaining cost, schedule, and performance parameters. The contractor shall provide periodic update reports to leadership. The contractor shall assess schedule risks and develop mitigation strategies. The contractor shall prepare acquisition documentation and presentations in support of major milestones, program reviews, or other program presentations. The contractor shall 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 review documentation (e.g., draft protocols, study plans, etc.) 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 assist in leading the project team and coordinate responsibilities, oversee quality management, and encourage timeliness of completion of drafting or reviewing 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 lead internal tech watch efforts and ensure coordination with external tech watch POCs to include but not limited to tracking summary documents, maintaining a tech watch database, and serving as the POC for CBRND Medical leadership on tech watch inquiries. The contractor shall review and search scientific literature and databases to identify technical information and to provide references to support product development efforts. 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 assist Government personnel in leading requirements generationefforts and development of RFPs, RFIs, SOOs, and other source selection documentation. The contractor shall participate in source selection activities, providing advice and assistance on the technical and programmatic value and feasibility of proposals to the Government. The contractor shall assist Government personnel in leading the analysis anddocumentation required for all contracting actions. The contractor shall assist Government personnel in leading the development and implementation of program planning budget and execution strategies, tracking and monitoring obligations and expenditures. The contractor shall receive debriefs at the Secret level on Biannual Threat Briefs and be able to assist on course of action development in support of IPT's. The contractor shall agree to a hybrid work environment and agree to being on-site at 1564 Freedman or 110 Thomas Johnson Drive twice per week to ensure maximum coordination with the program/product teams. The contractor shall receive debriefs at the Secret level on Biannual Threat Briefs and be able to assist on course of action development in support of IPT's. Qualifications Necessary Skills and Knowledge 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 maintain current knowledge of 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. Minimum Qualifications The contractor shall possess a Master's degree in Toxicology, Chemistry, Biology, 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 Toxicology, Chemistry, Biology, or a related discipline, as well as twelve (12) years of general experience and eight (8) years of relevant experience. The contractor shall possess a DAU Level II equivalency in Program Management or senior level DoD experience in pharmaceutical/biotechnology drug development portfolio management (i.e., investment decisions based on the risk management process). The contractor shall possess ten (10) years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval/licensure). The contractor shall possess 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 familiarity with, and have participated in, the discussion, preparation, and review of cycles required for program management, product development, acquisition program strategic planning, contract guidance, oversight, and advisory services The contractor shall possess five (5) years of working experience with Microsoft Office, including Outlook, Project, PowerPoint, Excel, and Word. Active SECRET security clearance Pay and Benefits The salary range for this position is $165,000 to $195,000. At Goldbelt, we value and reward our team's dedication and hard work. 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. #J-18808-Ljbffr Goldbelt Professional Services LLC