Scientific Project Manager I (GCLP Laboratory)

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 focuses on providing scientific leadership and laboratory infrastructure to study immune responses to HPV vaccines, influenza vaccines, and other cancer preventive strategies in the context of clinical and pre-clinical studies as well as gene therapy.

Key Roles/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 assessing 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.
• Maintain clinical study schedules, resources, and performance; 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, ensuring 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 submit manuscripts, and conduct statistical analyses, as required.
• Maintain a knowledge of the most recent literature and scientific presentations relevant to projects.

Basic Qualifications

• Possession of a PhD in immunology, virology or a related biomedical field from an accredited college or university according to the Council for Higher Education Accreditation (CHEA). 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 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 capable of completing 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 progressively responsible experience in program/project management.
• Progressively responsible experience must demonstrate increased independence and overall responsibility for more complex projects at a program/directorate level.
• Project Management Professional (PMP) certification.
• Regulatory knowledge pertinent to standards 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, software tools (Word, Excel, PowerPoint).
• Experience managing clinical immunological and vaccine studies and consortia activities.
• Experience working internationally in the areas of assay standardization.
• Experience with managing subcontracts, budgeting, cost estimates, and financial projections.