- 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 diagnostics for CBR threats.
- 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.
- Establish a link between clinical and non-clinical efficacy, developing a robust manufacturing strategy and defining product development schedules.
- Conduct data analyses and create and submit study results to use in market research or publications.
- Develop and/or review technical documentation.
- 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.
- 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.
- 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.
- 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).
- Write reports and briefs.
- Review the reports and briefs of other agencies.
- Standard Requirement: PhD in Engineering, Physics, Chemistry, Biology, Engineering Management, Pharm D, or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience.
- Tradeoff Requirement: Master's degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as twenty (20) years of general experience and fifteen (15) years of relevant experience.
- Ten (10) years of Industry experience in pharmaceutical/biotechnology advanced development (IND to FDA approval).
- Demonstrate pharmaceutical experience by providing evidence of patents achieved or multiple publications authored in peer-reviewed journals.
- Expertise in program management, product development, acquisition program strategic planning, contract guidance, oversight, and advisory services.
- Strong understanding of relevant literature and be able to effectively debate highly technical issues with other government and contractor experts.
- Five (5) years of working experience with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word.
- Preferred: Certifications below are desired and will be at no cost to the Government:
- Regulatory Affairs Certification (RAC)
- Diplomat of the American Board of Toxicology (DABT)
- Diplomat in Safety Pharmacology (DSP)
- Certification in Program Management (such as from the Program Management Institute)
- 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.
- Ten (10) years of experience in pre-clinical and clinical drugs, biologics, or assays advanced development (IND to FDA licensure).
- Previously served as the Director or Principal Investigator of a commercial pharmaceutical or biotechnology company with experience in filing IND applications, developing clinical protocols with the FDA, or participating in a project(s) involving completion of IND-enabling pre-clinical studies.
- Previously served as a team lead, with experience writing and reviewing multiple IND applications, 510ks submissions, PMAs, NDAs, BLAs, CLIA applications, DMF, clinical trial protocols, regulatory submissions, and technical reports.
- 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 and studies to evaluate efficacy of biodefense pharmaceuticals.
- 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.
- Active Secret clearance preferred; only candidates eligible for a Secret level clearance will be considered (US Citizenship required).
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Bioengineer V - Frederick, United States - LMI
Description
Overview
LMI is seeking a qualified Bioengineer V 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.Active Secret clearance preferred; only candidates eligible for a Secret level clearance will be considered (US Citizenship required).
LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers' unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.
Responsibilities
Performance Based Tasks Required:
Qualifications
