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 submit manuscripts, and conduct statistical analyses, as required.
- Maintain a knowledge of the most recent literature and scientific presentations relevant to projects.
- Perform other duties as assigned.
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- 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.
- Must have 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
Candidates with these desired skills will be given preferential consideration:
- A minimum of two to three (2-3) years progressively responsible experience in program/project management.
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Progressively responsible experience must demonstrate increased independence and overall responsibility for more complex projects at a program/directorate level.
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Project Management Professional (PMP) certification.
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Regulatory knowledge pertinent to standards GCLP, CLIA or FDA guidelines for clinical assays.
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Experience in immune assay (ELISA, multiple assays) development and validation under GCLP or GLP environment.
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Experience handling large data sets, statistics, software tools (Word, Excel, PowerPoint).
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Experience managing clinical immunological and vaccine studies and consortia activities.
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Experience working internationally in the areas of assay standardization.
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Experience with managing subcontracts, budgeting, cost estimates, and financial projections.
EXPECTED COMPETENCIES
- 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.
- Ability to identify and solve complex problems.
- Strong organizational and multitasking skills.
Commitment to Non-Discrimination
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.
Pay and Benefits
Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement.
103,100.00 - 147,767.00 USD
The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as 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
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