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Scientist
4 months ago
**Position Summary**
**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.
- 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.
