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 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. This position requires an active Secret clearance. You must be a U.S. citizen.

Essential Job Functions:

• 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.

Necessary Skills and Knowledge:

• Expertise in program management, product development, acquisition program strategic planning, contract guidance, oversight, and advisory services.
• Strong understanding of relevant literature and effectively debating highly technical issues with other government and contractor experts.
• Familiarity and expertise with designing and conducting non-clinical studies, including the 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 the efficacy of biodefense pharmaceuticals.
• Demonstrate proficiency in current reasonable 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:

• 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.
• Five (5) years of working experience with Microsoft Office, including Outlook, Project, PowerPoint, Excel, and Word.
• 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.
• Active Secret clearance preferred; only candidates eligible for a Secret level clearance will be considered (US Citizenship required).

Preferred Qualifications:

• 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)

The salary for this position is a minimum of $155,000 per year.

Pay and Benefits
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.