Animal Scientist jobs in Sierra Vista, AZ

Position Summary

The Design Transfer Scientist, as part of the Technical Operations department, will work with cross-functional core teams to ensure that products developed in Assay Development or Instrument Development are validated and optimized to be seamlessly transferred to the Manufacturing Operations group for efficient production. They will receive direction from the team lead and/or department head in the priorities of new and ongoing projects. The ideal candidate will have experience in in vitro diagnostics and a degree in microbiology, biochemistry, chemistry or molecular biology.

Roles and Responsibilities

• Represent Design Transfer on new product core teams.
• Participate in risk analyses (e.g. dFMEAs and pFMEAs).
• Prepare and participate in data reviews.
• Work cross-functionally (assay development, engineering, software, manufacturing, QC, QA, marketing) to bring devices to market.
• Work with development teams to:
  • Identify critical product characteristics and critical process parameters that affect those characteristics.
  • With QC Method Development, ensure appropriate product specifications are set.
  • Identify design flaws that could result in stability or reliability issues.
• Work with development and manufacturing personnel to transfer cGMP-compliant processes to manufacturing.
• Write protocols, reports, and other required documentation (e.g. validation master plan, transfer readiness reviews) as needed for the design history file.
• Write and execute stability plans, protocols, and reports to assign product expiration dating.
• Apply scientific principles and techniques to tasks and experiments.
• Support IQ/OQ/PQ for new equipment for product testing or manufacturing.
• Guide RAs and Associate Scientists in design transfer activities as required.

Formal Education / Relevant Experience

• BS in microbiology, biochemistry, chemistry, molecular biology, or related discipline 6 years’ relevant experience / MS 4 years / PhD 2 years.
• Previous experience working on new product or technology transfers in a regulated environment, preferably in vitro diagnostics. Experience in microbiology is desirable.

Knowledge, Skills, and Abilities

• Experience with design of experiments and statistical data analysis, including software (e.g. JMP, Minitab).
• Understanding of design control, good documentation practices (GDP) and good manufacturing practices (GMP) for medical device or in vitro diagnostics industry.
• Good understanding of product and process risk assessments.
• Familiar with ISO, IVD and other regulations as they relate to the in vitro diagnostics industry.
• Detail oriented with good time management skills.
• Drives cross-functional tasks in a fast-paced environment.
• Good interpersonal skills, verbal and written communication skills.
• Computer skills including Microsoft Windows, Word, Excel, and PowerPoint.
• Must be a self-starter, proactive, collaborative, and proficient at working both independently and in a team environment.
• Demonstrates critical and analytical thinking.