Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices. 

Summary:

Goldbelt Apex LLC is seeking a qualified Scientist IV to support our Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear (JPEO-CBRND) Joint Project Manager for Medical Countermeasure Systems (JPM MCS) client at our Ft. Detrick, MD location. This position requires an active Secret clearance. You must be a U.S. citizen.

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/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 in 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 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.
• 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 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 shall assist Government personnel in leading requirements generation efforts 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 and documentation 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.

Necessary Skills and Knowledge:

• 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.

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: 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.
• DAU Level II 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). DAU courses will be at Government cost; however, travel costs (ex: Per Diem, lodging, mileage) will not be at Government cost.
• Ten (10) years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).
• Five (5) years of experience in pre-clinical and clinical drugs, vaccines, biologics, assays, or diagnostics advanced development (IND to FDA licensure).
• Senior-level DoD experience in pharmaceutical/biotechnology vaccine and drug development portfolio management (i.e., investment decisions based on the risk management process).
• Five (5) years of working experience with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word.
• Only candidates eligible for a Secret level clearance will be considered (US Citizenship required).

Preferred Qualifications:

• Active Secret clearance preferred

The salary range for this position is $120,000 to $145,000 per year.

Pay and Benefits
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.