Scientific Project Manager

DRT Strategies, Inc.•Silver Spring, MD

3d•$80,000 - $100,000

About The Position

DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, state and local government and commercial clients in health care, technology, and financial services industries. The three letters of our name, DRT, stand for Driving Resolution Together, which is the core philosophy on which the company was founded. That is, we collaborate with our clients to solve their most pressing challenges - together. We are problem solvers dedicated to your success, combining Fortune 500 experience with small business responsiveness. We have established a reputation with our clients as a forward-thinking consulting firm with demonstrated success in implementing solutions that lead to meaningful results. Our world-class consultants unite people to work collaboratively to achieve project goals and make vision a reality. The position is in the Food and Drug Administration (FDA), the Office of the Commissioner (OC), Office of the Chief Scientist (OCS), Office of Regulatory and Emerging Science (ORES). The FDA is a Federal scientific agency with the legislated responsibility to protect and promote the public health of the Nation's consumers. ORES advances key regulatory science priorities, including innovative technologies, advanced manufacturing, and supply chain resilience, to strengthen FDA's ability to evaluate the safety, effectiveness, and quality of FDA-regulated products. ORES supports, funds, and conducts regulatory science research through both intramural and extramural programs. Intramural efforts are carried out by FDA scientists and staff working within FDA to develop and apply innovative tools, methods, and approaches that strengthen the agency's regulatory capabilities. Extramural efforts extend this work by funding and collaborating with academic institutions, research organizations, and other external partners to advance the broader regulatory science enterprise. Together, these complementary research programs enable ORES to identify and address emerging scientific challenges, inform evidence-based regulatory decision-making, and build the scientific foundation necessary to support FDA's mission. This position acts as the Project Manager for the Innovative Technologies Team in ORES, supporting initiatives that leverage advanced manufacturing to address critical supply chain vulnerabilities and advance regulatory science priorities. Under the direction of the Innovative Technologies Team Lead, the Project Manager applies their knowledge and professional skills to organize complex assignments that advance high-priority projects, manage operational functions of the Innovative Technologies Team, and support the team's broader mission and management functions.

Requirements

Bachelor's degree with 5+ years of experience required.
Bachelor's Degree in Engineering
Experience in supply chain and/or drug shortage framework.
Ability to obtain and maintain a U.S. government Public Trust clearance.
Candidates must be U.S. citizens or lawful permanent residents (green card holders) to be eligible.

Nice To Haves

Familiarity with advanced manufacturing technologies, such as continuous manufacturing, 3D printing, or other innovative production methods.
Knowledge of advanced manufacturing's role in supply chain resilience, drug shortages, or regulatory science.
Knowledge of FDA regulatory science priorities, frameworks, or programs; prior federal agency or government contracting experience a plus.
Experience coordinating multidisciplinary teams or managing relationships with academic, research, or external partner organizations.
Background in engineering preferred

Responsibilities

Develop and maintain project plans, schedules, milestones, deliverables, and documentation.
Manage strategic projects through the full life cycle using industry best practices.
Monitor project status across assigned portfolio; identify and resolve risks, delays, and issues.
Ensure project activities remain aligned with objectives and scope, coordinate deliverables and timelines.
Coordinate evaluations of Innovative Technologies Team projects and procedures.
Identify problem areas and best practices, recognize trends, and recommend program improvements.
Meet with managers, stakeholders, and collaborators to define goals and objectives of high-visibility projects.
Serve as point of contact for internal and external inquiries; draft and distribute meeting communications and program correspondence.
Prepare reports, presentations, and summaries.
Coordinate meetings and leadership discussions, including scheduling, agendas, materials, and logistics; support seminars, webinars, and other events.
Track action items and deadlines; capture meeting minutes and prepare technical and administrative reports.
Represent the Innovative Technologies Team on assigned groups.
Recommend integration of SMEs and coordinate with technical personnel as needed; prepare draft documents.
Maintain project trackers, calendars, stakeholder lists, shared documents, SOPs, and program resources.
Support development of processes, workflows, and templates; maintain program knowledge to support continuity of operations.
Coordinate cross-functional teams to support project goals and deliverables.