Scientist V

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 remain informed of the latest scientific innovations associated with biodefense therapeutics and advise the PM on developments that may impact the portfolio.

Essential Job Functions:

• The contractor shall provide the PM with scientific input to assist in the development of an overall biodefense therapeutic acquisition strategy. The contractor shall support and analyze development of medical technologies, to include:
  • Monitoring Industry to identify innovative technologies applicable to program goals
  • Evaluating proposals for medical technology development
  • Assessing technology readiness levels
  • Ensuring test protocols conform with FDA requirements
  • Identifying technical risks and recommending courses of action for risk mitigation
• The contractor shall provide support to the CTO, to include acting as the CTO's representative on IPTs and at other meetings, management of Taskers, drafting and reviewing documents, summarizing publications and data, and other related technical duties. Support is to be at a level commensurate with the educational requirements of the position - the contractor must have a solid understanding of the literature and be able to effectively debate highly technical issues with other contractors.
• 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 project management support in the areas of science and technology availability, technology maturity, and applicability of proposed candidate CBRN medical countermeasures through advanced development, production, and fielding. Support is to be at a level commensurate with the educational requirements of the position.
• The contractor shall possess expertise in program management, product development, acquisition program strategic planning, contract guidance, oversight, and advisory services.
• The contractor shall possess familiarity and expertise with all aspects of biologics cGMP (i.e., 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, and biologics license application preparation).
• 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 FDA Type A, B, and C meetings; and FDA qualification of drug development tools.
• 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 collaborate with both internal and external partners, contributing to data analyses to create and submit study results to publications or the FDA.
• The contractor shall provide advice for the development of research projects to produce effective solutions for maintaining cost, schedule, and performance parameters.
• The contractor shall provide bi-weekly update reports to the CTO.
• The contractor shall assist the program managers in assessing schedule risks and developing mitigation strategies.
• The contractor shall provide technical input to 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 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 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 develop drafts and assist the project team to coordinate responsibilities, oversee quality management, and encourage timeliness of completion of 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 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 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.
• The contractor shall possess the ability to perform multiple task simultaneously and rapidly redirect efforts based on changing requirements.
• The contractor shall possess strong writing and oral communication skills.

Minimum Qualifications:

• Shall possess a doctorate degree in Chemistry, Organic Chemistry, or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience.
  • Tradeoff Requirement: Master's degree in Chemistry, Organic Chemistry, or a related discipline, as well as twenty (20) years of general experience and fifteen (15) years of relevant experience.
• Shall possess senior level experience in pharmaceutical/biotechnology vaccine and drug development portfolio management (i.e., investment decisions based on the risk management process).
• Clearance: Secret

Preferred Qualifications:

• 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.