Project Manager II
Listed on 2026-08-26
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Business
Regulatory Compliance Specialist
Project Manager II
Job
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.
The Vaccine, Immunity and Cancer Directorate (VICD) has a primary mission to provide scientific leadership and laboratory infrastructure to study immune responses to Human Papillomavirus (HPV) vaccines and other cancer preventive strategies in the context of preclinical and clinical studies. As of recent and part of a large effort, the National Institute of Allergy and Infectious Diseases (NIAID) and the Frederick National Laboratory (FNL) and other stakeholders are developing vaccines with durable protection for seasonal influenza virus.
VICD is leading the development of immunoassays with the highest reproducibility, sensitivity, and specificity for evaluation of immune responses against the virus and vaccine.
VICD is recruiting for a Cross Functional Project Manager II to provide cross functional project management and programmatic operations. The ideal candidate will have prior experience working in a laboratory under the Good Clinical Laboratory Practices or GxP and is familiar with laboratory operations. The Cross Functional Project Manager II will report to the Director, Program and Operations, working with program directors, scientific managers and across matrix to meet the program and project goals, and assist and drive program activities to meet the deadlines for deliverables.
ROLES/RESPONSIBILITIES
- Assist in the management of research subcontracts supporting the program
- Manage administrative Program activities by performing a variety of high-level administrative and programmatic functions that include planning and implementation of overall Program strategies
- Communicate effectively to compose both business and scientific documents and ensure efficient Program operations
- Assist with overall coordination of Program/Project level functions
- Ensure Program compliance with all policies and procedures related to project management, contract relations, purchasing, and fiscal planning
- Provide meeting management support to Programs, including drafting agendas, meeting notes/minutes and recording, monitoring and follow-up action items with internal and external stakeholders as needed
- Assist in the preparation of program reports, including monthly quarterly reports, semi-annual and annual reports
- Assists with progress reporting, deliverables, and proposals, statement of work, and 508 compliance, other formal documents, formatting, editing, and submissions to appropriate systems and to stakeholders
- Assist with personnel actions such as requisition postings, onboarding and off-boarding activities such as office setup, computer and equipment setup, folder access, etc.
- Assists in the development of oral presentations and meetings with internal and external stakeholders
- Collaborate with internal and external stakeholders for intellectual property requirements, CRADAs, MTAs, collaboration agreements, subcontracts
- Work with managers to ensure laboratory and programs are operating in an efficient manner, providing administrative/operation support
- Working directly with the laboratory to perform equipment request processing, equipment management, coordinating vendors to certification completion
- Data entry for biological material inventory on an annual basis with accuracy
Liaise with internal groups and other L groups (HR, Finance, Purchasing, Equipment, etc.) as required - Perform other related duties as assigned
- Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
- In addition to the education requirement, a minimum of two (2) years of related experience managing research, experimental planning, proposal writing and project management
- Working knowledge and facility with Microsoft Office Suite
- Ability to obtain and maintain a security clearance
- Regulatory knowledge pertinent to standards GCLP, CLIA or FDA guidelines for clinical assays
- Familiarity with immunoassays, testing, equipment maintenance, LIMS
- Knowledge of CostPoint, Cognos, Corcentric, ERP
- Knowledge of finance and…
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