Bioengineer

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:

We are looking for a Bioengineer. The Bioengineer shall serve as the technical representative 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). The Bioengineer shall serve on internal and external IPTs, responsible for organizing meetings, preparing agendas, documenting meeting minutes and action items, and maintaining the document archive system.

Essential Job Functions:

• Provide written technical opinions to guide the decision-making process of the IPT.
• Participate in contractor site visits, assisting in monitoring performance, regulatory and quality standards, and providing technical oversight during study execution. The contractor shall serve as the programmatic representative at conferences and stakeholder meetings.
• 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, DoD acquisition processes, production, and fielding.
• 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.
• Shall collaborate with project teams and participate in the evaluation of technical results in multiple developmental areas, developing strategies to move the program forward.
• Shall collaborate with both internal and external partners, contributing to data analyses to create and submit study results to publications or the FDA.
• Shall collaborate with internal and external partners and research projects to produce effective solutions for maintaining cost, schedule, and performance parameters. The contractor shall provide periodic update reports to PMs.
• Assist the PMs in assessing cost and schedule risks and developing mitigation strategies.
• Shall draft and/or review acquisition documentation and presentations in support of major milestones, program reviews, or other program presentations.
• 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).
• Shall author, edit, and contribute to the development of robust product development plans to support FDA approval under the Animal Rule.
• 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.
• These activities will include collaboration with both internal and external partners.
• Develop drafts and assist the project team to coordinate responsibilities, oversee quality and regulatory management, and encourage timeliness of completion of protocols, IND applications, other regulatory submissions, and technical reports. Displaying results in "Layman's" terms, formulating conclusions, and developing technical strategies in response to the data outcomes.
• 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.
• Review and search scientific literature and databases in order to identify technical information and to provide references to support product development efforts.
• Assist to identify and assess risks of new technologies and ongoing projects.
• Shall prepare briefing materials.

Necessary Skills and Knowledge:

• Shall possess strong analytical and problem-solving skills, as well as good organization skills to balance and prioritize work.
• Possess extensive customer support/relations experience.
• Possess strong interpersonal and communication skills, both oral and written. The contractor shall possess five years of working experience with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word.
• Shall be capable of maintaining interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge across and within organizations united for the development of medical countermeasures.

Minimum Qualifications:

• Master's degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline as well as eight (8) years of general experience and five (5) years of relevant experience.
  • Tradeoff Requirement: The contractor shall possess a Bachelor's degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as ten (10) years of general experience and seven (7) years of relevant experience.
• Shall possess DAU Level I equivalency in Program Management or senior-level experience in pharmaceutical/biotechnology vaccine and drug development portfolio management (i.e., investment decisions based on the risk management process).
• Shall possess five (5) years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).
• Shall possess five (5) years of project management experience in cost, schedule, performance, risk analysis, and advice.
• Shall possess experience in pharmaceutical/biotechnology drug development portfolio management (i.e., investment decisions based on the risk management process).
• Must have a Secret clearance

Preferred Qualifications:

• The contractor may possess a Regulatory Affairs certification.
• May possess a Project Scheduling Professional certification. Specifically, the contractor shall possess 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 Integrated Master Schedules (IMSs) and financial documents.

Pay and Benefits

The salary range for this position is $160,000 to $195,700 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.