Immunologist Bioengineer V

Overview

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 Immunologist Bioengineer shall provide technical, scientific, and programmatic support to the program office and project teams, providing advice and assistance for advanced development efforts (i.e., clinical, non-clinical, and manufacturing) related to medical countermeasures for CBRN threats.

Hybrid - in the office 2-3 days/week.

Responsibilities

Essential Job Functions:

• 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.

Qualifications

Necessary Skills and Knowledge:

• 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.

Minimum Qualifications:

• 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.
  • Tradeoff Requirement: The contractor shall possess a Master's degree in Chemistry, Biology, Immunology or a related discipline, as well as thirty (30) years of general experience and twenty-five (25) 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 Qualifications:

• Preferred: Certifications below are desired and will be at no cost to the Government.
  • Project Management Professional (PMP) certification

Pay and Benefits

The salary range for this position is $150,000 - $175,000.00 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.