Text size A A

Mission

Applied Genetic Technologies Corporation (AGTC) is a clinical stage biotechnology company dedicated to developing novel gene therapies for ophthalmic diseases. The Research Associate II in Assay Development is responsible for developing and validating assays to ICH guidelines and transferring assays to contract organizations in support of human clinical material characterization and product commercialization activities.

Essential Duties and Responsibilities

  • Develop assay methods for viral-based gene therapeutic testing to support IND enabling non-clinical animal study material characterization and human clinical material release
  • Validate established assays for use in viral vector raw material characterization, process definition, late phase clinical material release and/or commercialization activities
  • Troubleshoot, optimize and refine assays for increased sensitivity, robustness, linearity and specificity
  • Participate in assay transfer activities, including contract vendor interactions, assay transfer, troubleshooting and oversight
  • Collect, analyze, record, and summarize data
  • Write and/or review SOPs, technical reports and study reports
  • Maintain relevant laboratory supplies and equipment as needed
  • Present scientific results at appropriate meetings
  • Knowledge of laboratory safety, OSHA policies, and EPA standards
  • Compliance with FDA regulations regarding GXP standards

 Educational Qualifications

  • A B.S. with 5 + years of experience or an M.S. with 3 + years of experience with a degree in a biological science and at least 2 years of industrial experience in assay development
  • Hands-on laboratory experience with in vitro assays encompassing immunology, molecular biology and/or cell biology such as ELISAs, PCR, and mammalian cell-based assays
  • Ability to develop new assay methods to ICH requirements with minimal supervision
  • Previous assay validation experience and knowledge of statistics is highly desirable

Additional Qualifications

  • Highly motivated with the ability to work independently and in a team
  • Detail oriented with strong written and verbal communication skills in English
  • Understanding/working knowledge of Microsoft Word, Excel and PowerPoint

 

AGTC offers a competitive compensation commensurate with education and experience. AGTC is an EOE and maintains a drug free workplace.  Please send CV or resume to: jobs@agtc.com

Visionary science for life changing cures.