Scientist, Product Validation and Compliance

Organization
DNA Genotek
Job Location
2 Beaverbrook Road
Ottawa, ON K2K 1L1
Canada
Job Description

DNA Genotek, a wholly owned subsidiary of OraSure Technologies Inc., is a Canadian biotech company that has become the recognized world leader in DNA collection products.  Our success is based on the strong relationships we've built with our customers and the exceptional talent of our employees.  We pride ourselves on offering a fun, positive and high performance environment that supports the continued growth and development of all employees.  We hope you are interested in joining our team as we are currently in search of a Scientist to join our Product Validation and Compliance group.

The successful candidate will assume responsibilities for R&D activities directed towards the introduction of future products to meet new market opportunities.  You will join a strong Research and Development science team and will be given the opportunity to grow and develop your career.

 Responsibilities will include:

  • Managing R&D studies for regulatory projects and product validation
  • Authoring documentation including study plans, risk analyses and study reports
  • Ensuring R&D activities are conducted in compliance with quality procedures and regulatory requirements
  • Providing guidance to R&D members on documentation standards and procedures
  • Interacting with Regulatory group and external regulatory agencies
  • Overseeing the validation of laboratory equipment and procedures
  • Managing project timelines, including directing Laboratory Technologist and Research Associate activities
  • Analysing, consolidating and summarizing laboratory results
  • Executing laboratory experiments as required
  • Participation in formal processes to support product introduction and testing
  • Working with a cross-functional team to manage regulatory studies and product validation projects
  • Making presentations to scientific staff and management
Requirements

Education:

  • PhD in molecular biology, biochemistry, cellular biology or other area of relevant biological sciences, plus a minimum of 3 years post-doctoral or an advanced degree with relevant work experience.

 

Experience:

  • Research experience in biology, biochemistry or cellular biology; strong background in nucleic acid research
  • Prior experience working in a regulatory, diagnostic, GLP, GMP or GCP environment
  • Knowledge and/or experience in validation principles, international regulatory requirements and quality standards (e.g. ISO 13485, FDA CFR Part 820)
  • Experience developing complex experimental designs within a research, clinical, diagnostic, and/or regulatory setting
  • Successful problem-solving skills, flexibility to adapt to changing project priorities, excellent communication skills, and the ability to work in an interdisciplinary team environment
  • Strong attention to detail; excellent documentation and writing skills
  • Strong project management skills
  • Ability to multitask and work under pressure to meet tight timelines
  • Experience supervising junior scientists or laboratory technicians is desirable
  • Statistical experience is desirable

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