Job Description
Scientific Project Manager I (GCLP Laboratory) Job ID: req4566 Employee Type: exempt full-time Division: Vaccine, Immunity and Cancer Directorate Facility: Frederick: ATRF Location: 8560 Progress Dr, Frederick, MD 21701 USA The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases. Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way. PROGRAM DESCRIPTION The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The Vaccine, Immunity, and Cancer Directorate (VICD) at the Frederick National Laboratory has a primary mission to provide scientific leadership and laboratory infrastructure to study immune responses to Human Papillomavirus (HPV) vaccines, influenza vaccines, other cancer preventive strategies in the context of clinical and pre-clinical studies as well as gene therapy. KEY ROLES/RESPONSIBILITIES VICD is looking for an energetic cross-functional Scientific Project Manager, with strong scientific background in immunology to support a highly visible initiative. This initiative involves many collaborators and studies with the overall aim of generating data that will contribute to implementation of new vaccines. The Scientific Project Manager will be responsible for both hands‑on laboratory science (including assay development under GCLP ad testing of clinical trial samples) and end‑to‑end project management (planning, work breakdown structures, schedules, budgets, deliverables, reporting, publications, subcontract management and stakeholder engagement). This is an onsite position with laboratory work. No telework option. Specific duties will include Support laboratory projects including sample management and testing, as well data analyses in a GCLP environment. Optimize and validate immune assay procedures and methodologies for assessment of immune response to infection and vaccines (e.g., ELISA, Luminex, flow cytometry, virus neutralization, ADCC, PCR, western blot). Work closely with Scientific Manager, Directors and collaborators to manage and provide project support. Provide scientific and administrative project management support, including drafting, revising technical responses, coordinating responses from internal teams to be included in Statements of Work, New Work Packages, and proposals. Translate strategic objectives into work breakdown structures, milestones, deliverables, deadlines, and budgets; keep plans current and visible. Monitor clinical study schedules, resources and performance, and assist with driving tasks to completion, making all necessary follow-up with stakeholders for timely responses. Generate and monitor all contractual deliverables and prepare any requested reports, ensure timely submissions. Organize and facilitate program meetings with internal and external stakeholders, including preparation of meeting materials and distribution, meeting minutes, manage action items, and other meeting logistics including scheduling and setting up appropriate meeting platforms. Manage subcontractors with financial tracking, progress reports, schedule, and assure project execution with established timelines, approve subcontractor invoices as required. Serve as technical project manager and subject matter expert for subcontracts involving, biospecimen acquisition, serology and immunology deliverables. Coordinate technical reviews of subcontractor proposals, consolidate feedback, and provide clear recommendations, as required. Perform scientific review of subcontractor proposals, provide technical comments as well as recommendations, coordinate all comments for feedback distribution. Develop scientific protocols and Standard Operating Procedures, and other scientific documents for the laboratory as required. In coordination with the VICD Operations Team, collaborate with internal and external stakeholders for intellectual property requirements, CRADAs, Material Transfer Agreements, Confidentiality Disclosure Agreements, other collaboration agreements, subcontracts, etc. Monitor clinical study schedules, and performance; proactively manage complex tasks and drive closure with timely stakeholder follow‑up. Lead oral presentations and meetings with internal and external stakeholders. Develop scientific proposals, write and sub