Project Manager

Description

Project Overview:

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 SFI 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.

Primary Responsibilities:

• •Manage strategic projects through the full life cycle using industry best practices.
• •Develop and maintain project plans, schedules, milestones, deliverables, and documentation.
• •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.

Requirements

• •Minimum of a bachelor’s degree in related field. (Masters preferred)
• •Minimum 5-7 years of experience is required.
• •PMP preferred
• •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.

Additional Information:

• •In order to meet the clearance requirements for this opportunity, candidates must be authorized to work in the US and be a US Citizen or Green Card holder.
• •Ability to pass a US Public Trust background investigation for access to the client site and computing systems. You must have lived in the US for the past three (3) years .
• •All candidates will be subject to a complete background check to include, but not limited to Criminal History, Education Verification, Professional Certification Verification, Verification of Previous Employment and Credit History.

Other Information:

• •The salary range for this position is $70,000 - $105,000 annually
• •For information on SFI's benefits please visit http://www.spatialfront.com/pages/career.html
• •This is a full-time remote position . Please no agencies, third parties, or corp-to-corp
• •Spatial Front Inc. is an Equal-opportunity Employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
• •Spatial Front Inc. participates in E-Verify