Scientist V (Doctor of Veterinary Medicine)

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 for the JPM CBRN Task Order 3 contract in the CTO Program Office

shall provide subject matter expertise to the CTO and/or JPM Medical during IPTs and at other meetings, providing written technical opinions to guide the decision-making process of the IPT, and effectively engaging other subject matter experts to effectively discuss and address complex technical issues.

Essential Job Functions:

• The contractor shall advise the program management team on product development, acquisition program strategic planning, contract guidance, and oversight.
• The contractor shall advise on various aspects of biologics cGMP (e.g., quality assurance, quality control, master cell bank production, working cell bank production validation, installation qualification, operating qualification, process qualification, engineering runs, process validation runs, consistency lot production, or biologics license application preparation).
• The contractor shall advise on 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 FDA Type A, B, and C meetings; and FDA qualification of drug development tools.
• The contractor shall 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 author, edit, and contribute to the development of robust product development plans to support FDA approval under the Animal Rule.
• The contractor shall prepare and/or review draft protocols and study plans pertaining to a range of developmental efforts (i.e., manufacturing, non-clinical, clinical, and assay development), providing feedback in support of advanced development efforts.
• 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 collaborate with both internal and external partners, contributing to data analysis to create and submit study results to publications or the FDA.
• The contractor shall provide advice on projects to produce effective solutions for maintaining cost, schedule, and performance parameters.
• The contractor shall assist with outreach activities, to include organizing visits, preparing agendas, providing information to visitors, documenting meeting summaries and action items, etc.
• 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 assist the program managers in assessing schedule risks and developing mitigation strategies.
• The contractor shall provide advice on the development, management, and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of GLP activities.
• The contractor shall provide technical input for acquisition documentation and presentations in support of major milestones, program reviews, or other program presentations.
• The contractor shall develop drafts and/or review and provide edits/comments on technical documentation (i.e., development/technology transfer reports, standard operating procedures, and regulatory submissions).
• The contractor shall perform data analysis and complete the review of technical reports, protocols, IND application, and other regulatory submissions within the required suspense date.
• 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 opinions on the feasibility of new technologies, and organizing brown bag seminars to allow the Joint Product Offices to review the 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.

Necessary Skills and Knowledge:

• Shall possess the ability to work on a multi-disciplined team in a DoD acquisition environment.
• Shall possess the ability to perform multiple tasks simultaneously and rapidly redirect efforts based on changing requirements.
• Shall possess strong writing and oral communication skills.
• Proficiency with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word.

Minimum Qualifications:

• Doctorate in Veterinary Medicine, with fifteen (15) years of general experience and ten (10) years of relevant experience conducting research on infectious diseases, studying immune response and viral replication between species, and performing toxicology study design and execution.
  • Tradeoff Requirement: The contractor shall possess a master's degree in molecular biology, biochemistry, microbiology, or virology, with fifteen (15) years of general experience and ten (10) years of relevant experience conducting research on infectious diseases, vaccine development, and program management.
• Possess and maintain DABT certification.
• Possess operational experience overseeing strategic animal research, use, and compliance programs.
• Possess experience performing Good Laboratory Practice (GLP) toxicologic and biologic safety and efficacy studies
• Clearance: Secret

Preferred Qualifications:

• Possess senior level experience in pharmaceutical/biotechnology vaccine and drug development portfolio management (i.e., investment decisions based on the risk management process).
• Have experience aligning FDA processes with DoD acquisition requirements for the development and procurement of medical products and systems for biodefense.

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.