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Scientist V

Goldbelt Professional Services LLC
vision insurance, paid time off, 401(k)
Jul 12, 2025
Overview

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 Scientist V shall provide technical, scientific, and programmatic support to the program office and project teams, providing advice and assistance for advanced development efforts (i.e., clinical, non-clinical, and manufacturing) related to medical countermeasures for CBR threats.


Responsibilities

Essential Job Functions:

  • The contractor shall serve as "Person in Plant" as needed to support performer site visits.
  • The contractor shall assist with Government oversight of development contractor efforts, to include conducting site visits, assisting in monitoring performance and quality standards, and providing technical oversight during study execution.
  • 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.

Qualifications

Necessary Skills and Knowledge:

  • Shall possess expertise in program management, product development, acquisition program strategic planning, contract guidance, oversight, and advisory services.
  • shall possess a strong understanding of relevant literature and be able to effectively debate highly technical issues with other government and contractor experts.
  • The contractor shall possess five (5) years of working experience with Microsoft Office, including Outlook, Project, PowerPoint, Excel, and Word.
  • 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 Code of Federal Regulations (CFR) 58) toxicity studies and US FDA Animal Rule (21 CFR 314.600 and 601.90) studies to evaluate efficacy of biodefense pharmaceuticals.

Minimum Qualifications:

  • PhD in Chemistry, Biology, Pharm D, or a related discipline, as well as twenty (20) years of general experience and eighteen (18) years of relevant experience.
    • Tradeoff Requirement: Master's degree in Chemistry, Biology, or a related discipline, as well as thirty (30) years of general experience and twenty-five (25) years of relevant experience.
  • Minimum twenty (20) years of Industry experience in toxicology, pharmaceutical**/biotechnology advanced development (IND to FDA approval). **The contractor shall demonstrate toxicology experience by providing evidence multiple publications authored in peer-reviewed journals and demonstrated experience writing toxicology protocols and running toxicology studies (all phases - protocol development, in-life, and reporting).
  • Minimum possess ten (10) years of experience in pre-clinical and clinical drugs, biologics, or assays advanced development (IND to FDA licensure).
  • The contractor shall have previously served as the Study Director or Principal Investigator of a commercial pharmaceutical or biotechnology company with experience in filing IND applications, developing clinical protocols with the FDA, or participating in a project(s) involving completion of IND- enabling pre-clinical studies.
  • The contractor shall have previously served as a team lead, with experience writing and reviewing multiple IND applications, 510ks submissions, PMAs, NDAs, BLAs, DMF, clinical trial protocols, regulatory submissions, and technical reports.
  • The contractor 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.
  • Clearance: Secret

Pay and Benefits

The salary range for this position is $170,000 to $250,000 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.

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