Goldbelt Hawk, LLC · 2 months ago
Immunologist Bioengineer V
Frederick, Maryland
Full-time
Hybrid
Senior Level, Lead/Staff
$150K/yr - $175K/yr
18+ years expGoldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support. The Immunologist Bioengineer shall provide technical, scientific, and programmatic support to the program office and project teams, focusing on advanced development efforts related to medical countermeasures for CBRN threats.
Information Technology
Responsibilities
Shall serve as “Person in Plant” as needed to support performer site visits
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
Shall drive collaboration across stakeholders and maintain strong technical and programmatic communication channels
Conduct data analyses and create and submit study results to use in market research or publications
Shall develop, review technical documentation and prepare decision-quality recommendations for government leadership
Provide program office support and participation at conferences and stakeholder meetings
Participate in internal and external IPTs, to include organizing meetings, preparing agendas, and documenting meeting minutes and action items
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.)
Research and review scientific literature and databases to identify technical information and provide references to support product development efforts
Review scientific data, reports, and technical submissions
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
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)
Will be required to write and review internal and external reports and briefs
Qualification
Required
Shall possess familiarity and expertise with designing and conducting non-clinical studies, including application of biostatistics to analyze study points and implementation of Good Laboratory Practices (GLP) (21 Code of Federal Regulations (CFR) 58) toxicity studies and US FDA Animal Rule (21 CFR 314.600 and 601.90) studies to evaluate efficacy of biodefense pharmaceuticals
Shall demonstrate proficiency in 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 DA Type A, B, and C meetings; and FDA qualification of drug development tools
Possess a PhD in Chemistry, Biology, Immunology, or a related discipline, as well as twenty (20) years of general experience and eighteen (18) years of relevant experience
Minimum twenty (20) years of Industry experience in immunology, pharmaceutical/biotechnology advanced development (IND to FDA approval). The contractor shall demonstrate immunology experience by providing evidence multiple publications authored in peer-reviewed journals and demonstrated experience writing immunology protocols and running immunology studies (all phases – protocol development, in-life, and reporting)
Minimum ten (10) years of experience designing studies to assess pre-clinical and clinical testing for safety, efficacy, and risk evaluation for drugs and therapeutic biologics
Shall possess expertise in program management, product development, acquisition program strategic planning, contract guidance, oversight, and advisory services. Defense Acquisition certification or equivalent highly desirable along with experience working in program management offices
The contractor shall possess a strong understanding of relevant literature and be able to effectively debate highly technical issues with other government and contractor experts. The contractor shall also be able to translate complex scientific and technical data into acquisition-relevant programmatic recommendations
Shall possess five (5) years of working experience with Microsoft Office tools (Outlook, Project, PowerPoint, Excel, Teams, OneNote and Word to manage schedules, deliverables and reporting requirements
Shall have previously served as a team lead, with experience writing and reviewing multiple IND applications, 510ks submissions, PMAs, NDAs, BLAs, DMF, clinical trial protocols, regulatory submissions, and technical reports
Preferred
Preferred: Certifications below are desired and will be at no cost to the Government
Project Management Professional (PMP) certification
Benefits
Medical, dental, and vision insurance
A 401(k) plan with company matching
Tax-deferred savings options
Supplementary benefits
Paid time off
Professional development opportunities
Company
Goldbelt Hawk, LLC
At GbHawk, we believe in collaborating with our clients to design, develop, and implement innovative and inventive solutions to support their missions.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase