Bioengineer Level: V

Goldbelt, Inc.•Frederick, MD

About The Position

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. The Bioengineer Level: V will serve as the primary programmatic representative on project teams, providing project management support and strategic advice for the advance development of CBRN medical countermeasures. Assist Project Managers in assessing cost, schedule, and performance risks, and take the lead in developing and implementing mitigation strategies. Lead the drafting, reviewing, and editing of acquisition documentation, including Statements of Work (SOWs), development plans, and presentations for program reviews. The JPEO-CBRND manages our nation's investments in chemical, biological, radiological, and nuclear defense equipment, and medical countermeasures. Battlespace worldwide. JPM CBRN Medical consists of the following product development organizations: Chemical Defense Pharmaceuticals (CDP): Provides the warfighter and the nation with robust and affordable U.S. Food and Drug Administration (FDA)-approved lifesaving MCMs against CBRN threats. CDP plays a critical and strategic role in chemical defense by providing the warfighter with protect-and-mitigate capabilities against known or novel threats.

Requirements

At least five (5) years of direct project management experience, demonstrating mastery in cost, schedule, performance, and risk analysis and mitigation.
Extensive customer support/relations experience and strong analytical, problem-solving, and organizational skills.
Master's degree in relevant scientific or engineering discipline (Engineering, Physics, Chemistry, Biology, Engineering Management, Pharm D, Virology, Microbiology, Molecular Biology, Biochemistry, Biochemical Engineering) with eight (8) years of relevant experience and five (5) years of relevant experience, OR a Bachelor's degree with a minimum of ten (10) years of relevant experience in managing complex technical programs.
Secret clearance.

Nice To Haves

Certification in Program Management (e.g., PMP)
DAU Level I (or higher) equivalency in Program Management
Project Scheduling Professional Certification
Experience aligning FDA processes with acquisition requirements for medical product development.

Responsibilities

Serve as the primary programmatic representative on project teams, providing project management support and strategic advice for the advance development of CBRN medical countermeasures.
Assist Project Managers in assessing cost, schedule, and performance risks, and take the lead in developing and implementing mitigation strategies.
Lead the drafting, reviewing, and editing of acquisition documentation, including Statements of Work (SOWs), development plans, and presentations for program reviews.
Extensive expertise in program management, product development, acquisition program strategic planning, and contract oversight.
Industry & Regulatory, serving as a Program Manager, Director, Principal Investigator, or team lead within a commercial pharmaceutical or biotechnology company, managing the development and filing of regulatory applications (e.g., IND, BLA, NDA, 510(k)).
Portfolio Management experience in pharmaceutical/biotechnology portfolio management, including making investment decisions based on a formal risk management process.
Demonstrate proficiency with Microsoft Project and Excel for managing resource-loaded Integrated Master Schedules (IMSs) and financial documents.
Strong understanding of the drug /biologic/diagnostic development process (from IND to FDA licensure) to effectively manage and oversee technical teams and debate issues with subject matter experts.