Bioengineer IV

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 IV shall serve as the technical representative/integrator on project teams, supporting risk planning efforts and providing advice and assistance in implementing process improvements for advanced development efforts (i.e., clinical, non-clinical, and manufacturing). Will also serve as the technical/programmatic lead on internal and external IPTs, responsible for organizing meetings, preparing agendas, documenting meeting minutes and action items, etc.

Essential Job Functions:

• The contractor shall serve as the technical/programmatic point of contact, participating in contractor site visits, assisting in monitoring performance and quality standards, and providing technical oversight during study execution.
• The contractor shall serve as the technical representative at conferences and stakeholder meetings.
• 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 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 conduct research projects to produce effective solutions for maintaining cost, schedule, and performance parameters. The contractor shall provide periodic update reports to leadership.
• The contractor shall assess schedule risks and develop mitigation strategies.
• The contractor shall prepare acquisition documentation and presentations in support of major milestones, program reviews, or other program presentations.
• The contractor shall 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 review documentation (e.g., draft protocols, study plans, etc.) 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 assist in leading the project team and coordinate responsibilities, oversee quality management, and encourage timeliness of completion of drafting or reviewing 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 on the feasibility of new technologies.
• The contractor shall review and search scientific literature and databases to identify technical information and to provide references to support product development efforts.
• 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 shall collaborate with both internal and external partners, reviewing study results being submitted to publications or the FDA. The contractor shall prepare and/or review documentation pertaining to contracting (e.g., SOWs, RFPs, Contracts, MOUs/MOAs, contract modifications, cost proposals, etc.)
• The contractor shall identify ways to fund the program, track program budget and spend plans, and assist in the yearly budget process and other finance-related activities.
• The contractor shall perform project assessment. In addition, the contractor shall participate in the development of project charters for new programs by compiling and analyzing gathered information (e.g., historical data, organizational factors, government requirements, stakeholder interest, etc.) The contractor shall conduct risk planning, to include developing a risk management plan which identifies, analyzes, and prioritizes risks and defines risk response strategies.
• The contractor shall perform stakeholder analysis and then develop and maintain stakeholder registers. The contractor shall manage flow of project information.
• The contractor shall develop project requirements based upon organizational needs and mission, align expectations, and gain support for projects.

Necessary Skills and Knowledge:

• Shall possess familiarity with, and have participated in, the discussion, preparation, and review of cycles required for program management, product development, acquisition program strategic planning, contract guidance, oversight, and advisory services.
• Possess five (5) years of working experience with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word.

Minimum Qualifications:

• Master's degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as ten (10) years of general experience and six (6) years of relevant experience.
  • Tradeoff Requirement: shall possess a Bachelor's degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as twelve (12) years of general experience and eight (8) years of relevant experience.
• pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).
• Minimum ten (10) years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).
• Minimum five (5) years of experience in pre-clinical and clinical drugs, vaccines, biologics, assays, or device advanced development (IND to FDA licensure).
• The contractor shall possess senior-level experience in pharmaceutical/biotechnology drug development portfolio management (i.e., investment decisions based on the risk management process).
• Clearance: Secret

Preferred Qualifications:

• DAU Level II equivalency in Program Management or senior level experience in pharmaceutical/biotechnology drug development portfolio management (i.e., investment decisions based on the risk management process) is desired. DAU courses will be at Government cost; however, travel costs (ex: Per Diem, lodging, mileage) will not be at Government cost.
• Certification in Program Management (such as from the Program Management Institute) is desired and will be at no cost to the Government.
• Regulatory Affairs certification is desired and will be at no cost to the Government.
• Project Scheduling Professional certification is desired and will be at no cost to the Government.
• Sufficient experience in the use of Microsoft Project and Microsoft Excel to provide a level of proficiency that allows independent development and management of resource loaded IMSs and financial documents is desired.
• Drug-delivery device combination product experience.

Pay and Benefits

The salary range for this position is $120,000 to $160,000 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.