Scientific Project Manager I (GCLP Laboratory)

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) provides scientific leadership and laboratory infrastructure to study immune responses to Human Papillomavirus (HPV) vaccines, influenza vaccines, other cancer preventive strategies in clinical and pre-clinical studies, and gene therapy.

About the role

VICD is seeking an energetic cross-functional Scientific Project Manager with a strong scientific background in immunology to support a highly visible initiative involving multiple collaborators and studies aimed at generating data to contribute to the implementation of new vaccines. This onsite position combines hands-on laboratory science with end-to-end project management, including planning, scheduling, budgeting, deliverables, reporting, publications, subcontract management, and stakeholder engagement. No telework option is available.

Responsibilities

• Support laboratory projects including sample management and testing, as well as 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 and revising technical responses, coordinating internal team responses for 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; assist with driving tasks to completion and follow up with stakeholders for timely responses.
• Generate and monitor all contractual deliverables and prepare requested reports to ensure timely submissions.
• Organize and facilitate program meetings with internal and external stakeholders, including preparation of meeting materials, distribution, meeting minutes, action items, and logistics.
• Manage subcontractors with financial tracking, progress reports, schedules, and ensure project execution within 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.
• Perform scientific review of subcontractor proposals, provide technical comments and recommendations, and coordinate feedback distribution.
• Develop scientific protocols, Standard Operating Procedures, and other scientific documents for the laboratory as required.
• Collaborate with the VICD Operations Team and internal/external stakeholders on intellectual property requirements, CRADAs, Material Transfer Agreements, Confidentiality Disclosure Agreements, and other collaboration agreements or subcontracts.
• 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 submit manuscripts, and conduct statistical analyses as required.
• Maintain knowledge of the most recent literature and scientific presentations relevant to projects.
• Perform other duties as assigned.

Requirements

• PhD in immunology, virology, or a related biomedical field from an accredited college or university (foreign degrees must be evaluated for U.S. equivalency).
• Expertise in tissue culture and immunological/virological techniques, including aseptic techniques, cell line maintenance, production of plasmids and virus-like particles, western blot, ELISA, Luminex assays, flow cytometry, virus neutralization assays, and PCR.
• Strong scientific knowledge of vaccines, immunology, virology, and serology.
• Experience with scientific/technical writing and documentation.
• Exceptional communication skills with the ability to communicate clearly with all levels of scientific personnel and administrative staff through written and oral presentations.
• Ability to multi-task and effectively prioritize and meet timelines in multiple concurrent projects.
• Ability to work independently in a dynamic environment and complete tasks with minimal supervision.
• Scientific competency in a field relevant and related to cancer and vaccine research.
• Ability to obtain and maintain a security clearance.

Preferred Qualifications

• A minimum of two to three (2-3) years of progressively responsible experience in program/project management, demonstrating increased independence and responsibility for complex projects at a program/directorate level.
• Project Management Professional (PMP) certification.
• Regulatory knowledge pertinent to standards such as GCLP, CLIA, or FDA guidelines for clinical assays.
• Experience in immune assay (ELISA, multiple assays) development and validation under GCLP or GLP environment.
• Experience handling large data sets, statistics, and software tools (Word, Excel, PowerPoint).
• Experience managing clinical immunological and vaccine studies and consortia activities.
• Experience working internationally in assay standardization.
• Experience with managing subcontracts, budgeting, cost estimates, and financial projections.

Skills

• In-depth understanding of immunology, immune assays, diagnostics, vaccines, and clinical research.
• Excellent communication skills (written and oral).
• Ability to work effectively in a matrix and team-oriented environment.
• Strong problem-solving skills.
• Strong organizational and multitasking abilities.

Pay

103,100.00 - 147,767.00 USD. The posted pay range is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include responsibilities of the job, education, experience, knowledge, skills, abilities, internal equity, and alignment with market data. The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part-time positions.

Benefits

• Competitive compensation.
• Health and Wellness programs.
• Income Protection.
• Paid Leave.
• Retirement benefits.