Research Associate III / Senior Research Associate - Assay Development

Company: AGTC
Location: Gainesville
Posted on: January 13, 2020

Job Description:

Mission The Research Associate III / Senior Research Associate, Assay Development Preclinical R&D is responsible for support of the Assay Development team by developing, qualifying, and transferring, assays in support of research, nonclinical and clinical programs. Reporting Relationship

• The Research Associate III / Senior Research Associate will report directly to the Supervisor, Assay Development Preclinical Research & Development Essential Duties and Responsibilities
  • Develop and qualify new assay methods for product release testing or in support of IND enabling non-clinical studies including in vitro cell based assays, immune assays and molecular assays.
  • Plan strategies for and participate in the development, qualification, and transfer of quantitative and semi-quantitative bioanalytical/bioassay methods to support preclinical, clinical programs and product release tests at CROs.
  • Maintain current knowledge of advancing technologies and propose their applications to ongoing projects.
  • Write and review assay development reports and standard test methods.
  • Independently plan, implement, and complete significant projects with minimal supervision.
  • Present results, conclusions, and implications to project teams and senior management and in appropriate meetings. Observe and comply with AGTC's Employee manual and safety and quality manual
  • Knowledge of laboratory safety, OSHA policies and FDA guidelines Educational Qualifications
    • Level III Research Associate - B.S. with at least five (5) years experience OR a M.S. with at least two (2) years experience with a degree in biological science and hands-on laboratory experience in molecular biology, virology, or related areas.
    • Senior Research Associate - B.S. with at least eight (8) years experience OR a M.S. with at least six (6) years experience with a degree in biological science and hands-on laboratory experience in molecular biology, virology, or related areas. Additional Qualifications
      • Experience working as part of a project team
      • Working knowledge of assay development, qualification and validation
      • Experience in developing large-molecule and biologics assays in a regulated environment to support some or all of the following: potency assays, titer assays, cell-based assays, transduction assays, infectivity assays, qPCR assays, immunoblotting, ELISA, or other ligand-binding assay technologies
      • Peer-reviewed publications or posters in the area of assay development a plus
      • Working knowledge of basic statistics
      • Knowledge of Microsoft Office Suite. Experience with SoftMax Pro or GraphPad Prism a plus. Supervisory Responsibilities
        • This position does not have supervisory responsibility Measures of Performance
          • An initial Performance Review will be completed three months from hire date.
          • After initial PR, reviews will be conducted annually within 60 days of the Company's fiscal year end
          • Weekly one-on-one meetings with the Supervisor, Assay Development Preclinical Research and Development for the review of work plans and data analysis

Keywords: AGTC, Gainesville , Research Associate III / Senior Research Associate - Assay Development, Other , Gainesville, Florida