Scientist - Tucson, United States - Accelerate Diagnostics Inc

Description

• Represent Design Transfer on new product core teams.
• Participate in risk analyses (e.g. dFMEAs and pFMEAs).
• Prepare and participate in data reviews.
• Work crossfunctionally (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 cGMPcompliant 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.
• Support IQ/OQ/PQ for new equipment for product testing or manufacturing.
• Guide RAs and Associate Scientists in design transfer activities as required.

• 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.

• 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 crossfunctional tasks in a fastpaced environment.
• Good interpersonal skills, verbal and written communication skills.
• Computer skills including Microsoft Windows, Word, Excel, and PowerPoint.
• Must be a selfstarter, proactive, collaborative, and proficient at working both independently and in a team environment.
• Demonstrates critical and analytical thinking.