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Company

Original Job Post

Goldbelt Apex LLC · 2 days ago

Bioengineer V / Senior Scientist

United States

Full-time

Remote

Senior Level

$155K/yr - $155K/yr

15+ years exp

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Government Administration

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Responsibilities

Provide technical, scientific, and programmatic support to the program office and project teams, advising on advanced development efforts related to medical diagnostics for CBR threats.

Assist with Government oversight of development contractor efforts, including monitoring performance, quality standards, and technical oversight during study execution.

Establish a link between clinical and non-clinical efficacy, develop a manufacturing strategy, and define product development schedules.

Conduct data analyses, create and submit study results for market research or publications.

Develop and review technical documentation.

Provide program office support at conferences and stakeholder meetings.

Participate in internal and external IPTs, organize meetings, prepare agendas, and document meeting minutes and action items.

Draft reports, executive summaries, significant actions, manuscripts, and other technical documents.

Research scientific literature and databases, review scientific data, reports, and technical submissions.

Communicate results orally and in written form, deliver work products within assigned deadlines.

Write reports and briefs, review reports and briefs of other agencies.

Qualification

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Pharmaceutical ExperiencePatents AchievedPublications AuthoredMicrosoft OfficeStudy DesignClinical TestingRisk EvaluationPre-clinical DevelopmentClinical DevelopmentAssay DevelopmentIND ApplicationsFDA RegulationsProject ManagementRegulatory SubmissionsTechnical ReportsRegulatory 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)

Required

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.

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).