Bioengineer IV/ Senior Scientist/Biological Systems Engineer/Manager - Business And Analysis

Overview

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices.

Summary:

Goldbelt Apex LLC is seeking a qualified Bioengineer IV to support our Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear (JPEO-CBRND) Joint Project Manager for Medical Countermeasure Systems (JPM MCS) client at our Ft. Detrick, MD location. This position requires an active Secret clearance. You must be a U.S. citizen.

Responsibilities

Essential Job Functions:

• 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).

• Serve as the technical/programmatic lead on internal and external IPTs, organizing meetings, preparing agendas, documenting meeting minutes and action items, etc.

• Serve as the technical/programmatic point of contact, participating in contractor site visits, monitoring performance and quality standards, and providing technical oversight during study execution.

• Serve as the technical representative at conferences and stakeholder meetings.

• Provide scientific/technology advice, technical oversight, and acquisition support in 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.

• 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.

• Provide written technical opinions to guide the decision-making process of the IPT.

• Collaborate with project teams and participate in evaluating technical results in multiple developmental areas, developing strategies to move the program forward.

• Conduct research projects to produce effective solutions for maintaining cost, schedule, and performance parameters.

• Provide periodic update reports to leadership.

• Assess schedule risks and develop mitigation strategies.

• Prepare acquisition documentation and presentations in support of significant milestones, program reviews, or other program presentations.

• Review and provide edits/comments to technical documentation (i.e., development/technology transfer reports, batch records, standard operating procedures, and regulatory submissions).

• Author, edit, and contribute to developing robust product development plans to support FDA approval under the Animal Rule.

• 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. These activities will include collaboration with both internal and external partners.

• 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.

• Prepare documentation/presentations summarizing technical results, including displaying results in "Layman's" terms, formulating conclusions, and developing technical strategies in response to the data outcomes.

• Maintain current knowledge of new technologies and methodologies that may benefit the program, critically and effectively assess technical proposals, and provide written technical opinions on the feasibility of new technologies.

• Review and search scientific literature and databases to identify technical information and provide references to support product development efforts.

• Communicate results of assigned tasks and efforts, both orally and in written form, clearly and concisely, to include executive summaries, meeting presentations, documentation, and reports.

• 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 before Government approval and submission).

• Assist Government personnel in leading requirements generation efforts and developing RFPs, RFIs, SOOs, and other source selection documentation.

• Participate in source selection activities, providing advice and assistance on the technical and programmatic value and feasibility of proposals to the Government.

• Assist Government personnel in leading the analysis and documentation required for all contracting actions.

• Assist government personnel in leading the development and implementation of program planning budget and execution strategies, as well as tracking and monitoring obligations and expenditures.

Qualifications

Necessary Skills and Knowledge:

• Familiarity with and participation in the discussion, preparation, and review of cycles required for program management, product development, acquisition program strategic planning, contract guidance, oversight, and advisory services.

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 preferred.

• Tradeoff Requirement: 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 preferred.

• Possess a DAU Level II equivalency in Program Management or senior-level DoD experience in pharmaceutical/biotechnology vaccine and drug development portfolio management (i.e., investment decisions based on the risk management process). DAU courses will be at government cost; however, travel costs (e.g., per diem, lodging, mileage) will not be government cost.

• Possess ten (10) years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).

• Possess five (5) years of experience in pre-clinical and clinical drugs, vaccines, biologics, assays, or diagnostics advanced development (IND to FDA licensure).

• Possess senior-level DoD experience in pharmaceutical/biotechnology vaccine and drug development portfolio management (i.e., investment decisions based on the risk management process).

• Possess five (5) years of working experience with Microsoft Office, including Outlook, Project, PowerPoint, Excel, and Word.

• Active Secret clearance. You must be a U.S. citizen.

The salary range for this position is $110,000 to $135,000 per year.

Pay and BenefitsAt 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.