• Project Coordinator

    Posted Date 3 weeks ago(10/24/2018 1:14 PM)
    Job ID
    2018-3228
    # of Openings
    1
    Job Location(s)
    US-MD-Bethesda
    Category
    Science
  • Overview

    Medical Science & Computing (MSC) is an exciting growth oriented company, dedicated to providing mission critical scientific and technical services to the Federal Government. We have a distinguished history of supporting the National Institutes of Health (NIH) and other government agencies. MSC offers a dynamic and upbeat work environment, excellent benefits and career growth opportunities.

     

    We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, Pre-Tax Transit Assistance and tuition reimbursement. If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!

     

    Duties & Responsibilities

    Medical Science & Computing is searching for a Project Coordinator to support the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and is on-site in Bethesda, MD.

     

    The Project Coordinator is responsible for supporting the management of vaccine development initiatives, including the production of vaccines for Phase 1 and 2 vaccine trials. The Project Coordinator will coordinate the production, quality control, formulation, quality assurance and other components of the vaccine development process within the lab. The Project Coordinator will also be responsible for supporting the head of the Vaccine Production and CMC unit, contractors and other external contributors to multiple concurrent vaccine initiatives.

     

    Under the supervision of the Program Manager, the Project Coordinator will play a key role in the coordination of a series of technical steps performed by the branch units, which include:

     

    • Development of expression systems capable of producing sufficient clinical grade material for clinical trials
    • Development of a purification process for producing clinical grade antigen
    • GMP production of the bulk antigen.
    • Detailed immunogenicity studies to determine promising formulations and doses for vaccine trials
    • Production of clinical grade formulated vaccine
    • Supporting the development and implementation of QC procedures for assaying purity, integrity, stability and potency of the bulk antigen and formulated products
    • QA review of the data from protocols, procedures and assays conducted by staff
    • Pre-clinical toxicology studies
    • Preparation of IND and other regulatory documents
    • Conduct of Phase 1 and 2 clinical trials

    The Project Coordinator will need to exercise skill and judgment in coordinating these steps with head of the Vaccine GMP Production unit within the branch and the Program Manager. The responsibilities required to effectively coordinate these technical steps will include:

     

    • Milestones for determining progression of the project from one stage to another
    • Resource identification for each task
    • Monitoring the progress of tasks undertaken by internal branch units and external contractors/collaborators.  Initiate early remedial action where agreed timelines are not likely to be achieved.
    • Leading meetings, addressing project related activities and distributing subsequent action plans. 
    • Organize and maintain data generated by technology units, published literature, or other reports that are relevant to the projects. Regularly analyze these data and through informal and formal mechanisms ensure that:
    • Along with the Program Manager, develop new proposals to address specific issues facing projects.  These may include:
      • Impact of new insights on the structure or function of the antigen or testing of an effective vaccine
      • Opportunities afforded by newly developed systems or models on the development of an effective vaccine
      • Immune response to the antigen and its impact on the choice of formulation
    • Coordinate and actively participate in the publication of data and other material relating to the project. Publications may include papers in scientific journals, presentations at Scientific Meetings, documents for regulatory purposes (especially IND applications), draft patents, and reports for funding agencies

    Requirements

    • Bachelor’s Degree in biology, microbiology, chemistry or biochemistry
    • Minimum 5 years project management experience in pharmaceutical or biotechnology industries or related research and development organizations
    • Knowledge of current Good Laboratory Practices and current Good Manufacturing Practices
    • Knowledge of FDA drug approval process, particularly IND preparation
    • Experience preparing laboratory protocols as well as regulatory documents.
    • Experience with vaccine research and development
    • Demonstrated organizational skills are essential, and strong written and oral communication skills are required.
    • Experience with MasterControl software a plus.

     

    Medical Science & Computing is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

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