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Goldbelt Apex LLC · 2 days ago
Scientist IV
Fort Detrick, MD
Full-time
Onsite
Senior Level
$120K/yr - $145K/yr
10+ years exp
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Responsibilities
The contractor 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).
The contractor shall serve as the technical/programmatic lead on internal and external IPTs, responsible for organizing meetings, preparing agendas, documenting meeting minutes and action items, etc.
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 to 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. These activities will include collaboration with both internal and external partners.
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 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 to allow for Government review, revision, and coordination prior to Government approval and submission.
The contractor shall assist Government personnel in leading requirements generation efforts and development of RFPs, RFIs, SOOs, and other source selection documentation.
The contractor shall participate in source selection activities, providing advice and assistance on the technical and programmatic value and feasibility of proposals to the Government.
The contractor shall assist Government personnel in leading the analysis and documentation required for all contracting actions.
The contractor shall assist Government personnel in leading the development and implementation of program planning budget and execution strategies, tracking and monitoring obligations and expenditures.
Qualification
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Required
Master’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline
Ten (10) years of general experience and six (6) years of relevant experience
DAU Level II equivalency in Program Management or senior level DoD experience in pharmaceutical/biotechnology vaccine and drug development portfolio management
Ten (10) years of Industry experience in pharmaceutical/biotechnology advanced development
Five (5) years of experience in pre-clinical and clinical drugs, vaccines, biologics, assays, or diagnostics advanced development
Senior-level DoD experience in pharmaceutical/biotechnology vaccine and drug development portfolio management
Five (5) years of working experience with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word
Only candidates eligible for a Secret level clearance will be considered (US Citizenship required)
Preferred
Active Secret clearance preferred
Benefits
Medical Insurance
Dental Insurance
Vision Insurance
401(k) Plan with Company Matching
Tax-deferred Savings Options
Supplementary Benefits
Paid Time Off
Professional Development Opportunities
Company
Goldbelt Apex LLC
Goldbelt Apex is an Alaska Native Small Business Administration certified 8(a), wholly owned subsidiary of Goldbelt, Inc.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Aaron Seib
Chief Data Interoperability Officer
Company data provided by crunchbase
