Scientific Project Manager I (GCLP Laboratory)

About the Role

The Frederick National Laboratory, operated by Leidos Biomedical Research, Inc., addresses urgent and intractable problems in biomedical sciences, including cancer, AIDS, drug development, nanotechnology in medicine, and emerging infectious diseases. The Vaccine, Immunity, and Cancer Directorate (VICD) provides scientific leadership and laboratory infrastructure to study immune responses to vaccines (e.g., HPV, influenza) and gene therapy in clinical and pre-clinical studies.

This onsite position involves both hands-on laboratory science and end-to-end project management for a highly visible initiative aimed at generating data to support new vaccine implementation. The role requires collaboration with multiple stakeholders and studies, with no telework option.

Responsibilities

• Support laboratory projects, including sample management, testing, and data analysis in a GCLP environment.
• Optimize and validate immune assay procedures (e.g., ELISA, Luminex, flow cytometry, virus neutralization, ADCC, PCR, western blot) for assessing immune responses to infection and vaccines.
• Work closely with Scientific Manager, Directors, and collaborators to provide project support.
• Provide scientific and administrative project management, including drafting technical responses, coordinating Statements of Work, New Work Packages, and proposals.
• Translate strategic objectives into work breakdown structures, milestones, deliverables, deadlines, and budgets; maintain current and visible plans.
• Monitor clinical study schedules, resources, and performance; drive tasks to completion with timely stakeholder follow-up.
• Generate and monitor contractual deliverables, prepare reports, and ensure timely submissions.
• Organize and facilitate program meetings, including preparation of materials, meeting minutes, action items, and logistics.
• Manage subcontractors, including financial tracking, progress reports, schedules, and invoice approvals.
• 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 recommendations.
• Perform scientific review of subcontractor proposals, provide technical comments, and coordinate feedback distribution.
• Develop scientific protocols, Standard Operating Procedures, and other laboratory documents.
• Collaborate with the VICD Operations Team on intellectual property requirements, CRADAs, Material Transfer Agreements, Confidentiality Disclosure Agreements, and other collaboration agreements.
• 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 recent literature and scientific presentations relevant to projects.

Requirements

• PhD in immunology, virology, or a related biomedical field from an accredited institution (foreign degrees must be evaluated for U.S. equivalency).
• Expertise in tissue culture and immunological/virological techniques, including aseptic techniques, cell line maintenance, plasmid production, 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 for interacting with scientific and administrative personnel.
• Ability to multi-task, prioritize, and meet timelines across multiple concurrent projects.
• Ability to work independently in a dynamic environment with minimal supervision.
• Scientific competency relevant to cancer and vaccine research.
• Ability to obtain and maintain a security clearance.

Preferred Qualifications

• 2–3 years of progressively responsible experience in program/project management, demonstrating increased independence and responsibility for complex projects.
• Project Management Professional (PMP) certification.
• Regulatory knowledge of GCLP, CLIA, or FDA guidelines for clinical assays.
• Experience in immune assay development and validation under GCLP or GLP environments.
• Experience handling large datasets, statistics, and software tools (Word, Excel, PowerPoint).
• Experience managing clinical immunological and vaccine studies and consortia activities.
• International experience in assay standardization.
• Experience managing subcontracts, budgeting, cost estimates, and financial projections.

Skills

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

Pay

The posted pay range for this full-time position is $103,100.00 – $147,767.00 USD. The range is a general guideline and may vary based on factors such as job responsibilities, education, experience, knowledge, skills, internal equity, and market alignment. Part-time positions will be compensated proportionally.

Benefits

Leidos offers competitive compensation packages, including Health and Wellness programs, Income Protection, Paid Leave, and Retirement benefits. More details are available on the Leidos benefits page.