DUTIES

  • Lead molecular diagnostic assay development in a hands-on manner through successful FDA submission
  • Manage and contribute to regulatory documents
  • Project management; personnel management skills preferred
  • Design assay performance specifications
  • Ensure assay development process meets milestones and timelines
  • Troubleshoot and solve technical issues
  • Maintain compliant laboratory documents and procedures
  • Pro-actively improve efficiency, quality and effectiveness of R & D efforts

QUALIFICATIONS

  • PhD in Nucleic Acids Biochemistry, Molecular Biology, or related field
  • Minimum of 7 years of relevant industry experience and IVD assay development
  • In depth knowledge and hands on experience with qPCR, sequencing and standard molecular biology techniques
  • Demonstrated technical, managerial and leadership expertise in assay development
  • Strong understanding of FDA and global regulatory requirements
  • Prefer commercial assay experience
  • Demonstrated experience and understanding of quality systems (e.g., GLP, ISO, etc.)
  • Prefer experience working in BSL-2 laboratory facilities
  • Strong work ethic and ability to generate high quality work under tight deadlines
  • Flexibility in work schedule
  • Self-motivated, independent and a driving force of efficient execution
  • Strong organizational and project management skills
  • Excellent oral and written communication skills
Submit Resume

To apply for this job email your details to info@clinlabstaffing.com