Immunologist Bioengineer V

Immunologist Bioengineer V – Goldbelt Professional Services

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. Goldbelt’s research‑driven approach creates solutions customized to the client’s needs.

Summary

The Immunologist Bioengineer shall provide technical, scientific, and programmatic support to the program office and project teams, offering advice and assistance for advanced development efforts (clinical, non‑clinical, and manufacturing) related to medical countermeasures for CBRN threats. Hybrid – in the office 2‑3 days/week.

Responsibilities

• Serve as “Person in Plant” as needed to support performer site visits.
• Assist with Government oversight of development contractor efforts, including site visits, monitoring performance and quality standards, and providing technical oversight during study execution.
• Drive collaboration across stakeholders and maintain strong technical and programmatic communication channels.
• Conduct data analyses and create and submit study results for use in market research or publications.
• Develop, review technical documentation and prepare decision‑quality recommendations for government leadership.
• Provide program office support and participation at conferences and stakeholder meetings.
• Participate in internal and external IPTs, organizing meetings, preparing agendas, and documenting minutes and action items.
• Draft reports, including executive summaries, significant actions, manuscripts, and other technical documents (technology transition agreements, concept transition agreements, requests for proposals, statements of work, etc.).
• 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, to include executive summaries, meeting presentations, documentation, and reports.
• Deliver written work products no later than the assigned suspense.
• Write and review internal and external reports and briefs.

Qualifications

• Shall possess familiarity and expertise with designing and conducting non‑clinical studies, including application of biostatistics to analyze study points and implementation of Good Laboratory Practices (GLP) (21 CFR 58) toxicity studies and US FDA Animal Rule (21 CFR 314.600 and 601.90) studies to evaluate efficacy of biodefense pharmaceuticals.
• 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.
• Possess a PhD in Chemistry, Biology, Immunology, or a related discipline, plus twenty (20) years general experience and eighteen (18) years relevant experience.
• Tradeoff Requirement:
  The contractor shall possess a Master’s degree in Chemistry, Biology, Immunology or a related discipline, plus thirty (30) years general experience and twenty‑five (25) years relevant experience.
• Minimum twenty (20) years of industry experience in immunology, pharmaceutical/biotechnology advanced development (IND to FDA approval). Demonstrate immunology experience by providing evidence of multiple peer‑reviewed publications and experience writing immunology protocols and running immunology studies (all phases – protocol development, in‑life, and reporting).
• Minimum ten (10) years of experience designing studies to assess pre‑clinical and clinical testing for safety, efficacy, and risk evaluation for drugs and therapeutic biologics.
• Shall possess expertise in program management, product development, acquisition program strategic planning, contract guidance, oversight, and advisory services. Defense Acquisition certification or equivalent highly desirable along with experience working in program…