Provide services as a Scientific Program Manager in support of the overall functions of the Vaccine Research Center within the National Institute of Allergy and Infectious Diseases (NIAID).

BASIC QUALIFICATIONS:

• Master’s degree in biological sciences is required.
• Minimum of fifteen (15) years of experience in project management working with small molecules, therapeutic antibodies, vaccines, and other protein products in infectious diseases and biodefense is required.

MINIMUM QUALIFICATIONS:

• Ability to communicate effectively, orally and in writing, in a high stress environment with non-technical and technical staff.
• Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
• This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.
  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.
  Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.
  This position is contingent upon contract award

• Apply expert scientific knowledge of the pharmaceutical product development process to guide VRC product portfolio management. This includes clarifying critical problems, developing, and implementing solutions, resolving gaps in skills or capacity of the project management staff needed to accomplish the work, assessing options and their impact on project costs, quality of work products, and timeliness of completion of tasks.
• Ensure that project plans are consistent with the long-term mission and available resources of the Office of Strategic Development (SPD), VRC and the VRC Office of the Director (OSD) and specify the responsible organizational component and staff to be assigned to each task and/or activity.
• Assist the Director of the Vaccine Production Program in the development and technology transfer of manufacturing processes, formulations, and analytical procedures to enable Good Manufacturing Practices (GMP) production of various vaccines, antibodies, and adjuvants.
• Oversee the Vaccine Clinical Materials Program (VCMP) in the GMP production of vaccines, antibodies, and adjuvants to meet VRC clinical trial objectives.
• Generate high producing cell lines and optimize their growth conditions to enable sufficient expression to meet program goals for clinical trial material.
• Develop robust downstream processes to ensure purity and potency of the clinical trial material is suitable for human use, as well as provides sufficient viral clearance to meet regulatory requirements (as needed).
• Establish analytical assays including purity, potency, and identity assays to confirm the quality of material is suitable for human use and are sufficient to monitor the stability of the material.
• Support strategic initiatives of VRC leadership including establishment of project management resource tools to enable dissemination of project progress across the entire VRC portfolio.
• Establish and coordinate the flow of dependencies between project tasks and ensure that project plans are well organized and there are adequate tools to manage the project among the various functional and organizational components involved in the project.
• Monitor, assess, and communicate to VRC leadership, project management staff, interagency
• partners, external collaborators, and VRC project teams the status and progress of all projects within the VRC development portfolio, issues/problems, emerging scheduling conflicts or opportunities to accomplish the work.
• Use critical path analysis and/or comparable project management tools to track progress and make recommendations on prioritization of projects.
• Monitor deadlines and other benchmarks to ensure that VRC activities are meeting stipulated obligations.
• Apply situationally appropriate project management practices to guide research teams to successful completion of projects, to keep activities on schedule, and to facilitate an effective project that best meets VRC and NIAID goals.
• Originate, formulate, and disseminate project information, assessments, and evaluations to ensure that VRC leadership is properly apprised of progress and their views concerning project activities are properly disseminated in order to integrate project activities across the organization.
• Identify current or emerging issues affecting projects tasks/activities and/or the accomplishment of scientific objectives, the sequencing of activities, activity completion times.
• Generate a range of project planning options and relevant information to assist in the formulation of effective policies and procedures and ensure that each plan is a complete and accurate expression of all necessary tasks to accomplish the project’s objectives.
• Provide expertise and guidance designing and conducting preclinical safety toxicology studies, preclinical tissue-cross reactivity studies, and other IND-enabling proof of concept research.
• Serve as a technical and scientific advisor to SPD, Vaccine Production Program (VPP), and VRC OSD on the translational processes leading to the manufacture of a pharmaceutical product particularly as pertinent to biologics and vaccines and to coordinate the design and conduct of projects where the specifics of the project are difficult to determine in advance.
• Facilitate communication and resolution of conflicts among different organizational groups with varying interests or concerns that may conflict with project timetables, scientific requirements, availability of staff and/or staff time, available resources, and sequencing demands.
• Continuously collaborate with the VRC managers, laboratory heads, principal investigators, and other personnel to identify, devise, implement, and maintain improvements in the management of vaccine development and manufacturing projects.