Bioengineer 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 Bioengineer 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.

Essential Job Functions:

• 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.
• 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.
• The contractor shall provide support at a level commensurate with the educational requirements of the position. The contractor shall provide support to the CTO, including but not limited to the following actions:
  • Representing CTO on IPTs and at other meetings
  • Performing task management
  • Drafting and reviewing documents
  • Summarizing publications and data
• 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 provide written technical opinions to guide the decision making process of the IPT.
• The contractor shall collaborate with both internal and external partners, contributing to data analyses in order to create and submit study results to publications or the FDA.
• The contractor shall assist with outreach activities, including but not limited to the following actions:
  • Organizing visits
  • Preparing agendas
  • Providing information to visitors
  • Documenting meeting summaries and action items
• The contractor shall assist the program managers in assessing schedule risks and developing mitigation strategies.
• 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 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 provide advice for the development of research projects to produce effective solutions for maintaining cost, schedule, and performance parameters.
• 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 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 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 on the feasibility of new technologies, and organizing brown bag seminars to allow the Joint Product Offices to review the technologies.
• The contractor shall provide bi-weekly update reports to the CTO.

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 five (5) years of working experience with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word. The contractor shall possess senior-level experience in pharmaceutical/biotechnology vaccine and drug development portfolio management (i.e., investment decisions based on the risk management process).
• The contractor shall demonstrate proficiency in the following:
• 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
• FDA qualification of drug development tools
• Familiarity of and expertise with all aspects of biologics current good manufacturing procedures (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).

Minimum Qualifications:

• PhD in Virology, Chemistry, Biology, 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 Virology, Chemistry, Biology, Microbiology, 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 the pharmaceutical/biotechnology industry focused on advanced development (IND to FDA approval). The contractor shall demonstrate pharmaceutical experience by providing evidence of multiple publications authored in peer- reviewed journals or demonstrated product development of antivirals, vaccines or chemical therapeutics to FDA approval.
• Clearance: Secret

Preferred Qualifications:

• May possess experience aligning FDA processes with FDA acquisition requirements for the development of medical products and systems for biodefense.

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.