Director, Technology Development

Opportunity and Responsibilities

The Director of Technology Development will report to the VP of Research & Development. The individual in this role will be responsible for assessing protein analysis technologies and identifying and optimizing platforms for use in analyte research, assay development and commercial products. In addition, this person will be responsible for the development of assays for research analytical platforms and commercial products. The individual will play a key role in the design and development Aviir’s first product through the development of systems and processes, and preparation of procedures, data and reports.

The specific responsibilities of this position are:

  • Perform assessment of available protein analysis technology platforms and their feasibility for research and commercial applications.
  • Develop and optimize commercial assays including:
    • Participating in the development of product specifications for Aviir’s in-vitro diagnostic products
    • Developing assays in accordance with Aviir’s product development procedures, including assay verification and validation.
    • Developing process controls and quality controls for assays and manufacturing processes. Producing the Device Master Record (DMR) for GMP manufacture of reagents and participating in the qualification of contract manufacturers.
    • Managing manufacturing transfer activities
    • Preparing reports for regulatory submissions
  • Develop and optimize, research assays including:
    • Identifying and optimizing the analytical platform
    • Developing and optimizing assays
    • Writing methods and procedures

Qualifications

  • PhD with at least 10 years work experience, with at least 5 years in protein analytical chemistry
  • At least 5 years experience in working in a GMP/ISO 13485 regulated environment
  • Strong knowledge of protein analysis technology platforms and a successful track record of development and implementation of assay systems and protocols
  • Experience in supervision and management of scientific teams
  • Prior experience in the preparation of regulatory documents
  • Strong analytical/reasoning skills and problem solving abilities
  • Excellent written and verbal communication skills, ability to present information to a wide range of groups/entities

To apply, please send a cover letter and resume to jobs@aviir.com with the title of the position in the subject line.