Bioengineer V (Senior Scientist)

Please note that this position is contingent upon the successful award of a contract currently under bid.

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 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:

• 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.
• The contractor shall participate in Technical Advisory Panels and interface with the TRAB to assist in TRAs.
• 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.

Necessary Skills and Knowledge:

• Shall possess expertise in program management, product development, acquisition program strategic planning, contract guidance, oversight, and advisory services.
• The contractor shall possess a strong understanding of relevant literature and be able to effectively debate highly technical issues with other contractors.
• The contractor shall possess a working proficiency with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word.
• The contractor shall 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. **The contractor shall demonstrate pharmaceutical or diagnostic 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 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. DAU courses will be at Government cost; however, travel costs (ex: Per Diem, lodging, mileage) will not be at Government cost.

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.