Job Description: We are seeking a highly motivated scientist to join our Diagnostics group. The major responsibilities for this individual include but are not limited to:
Work closely with the development team to contribute to the development of real-time PCR based IVD tests.
Perform some design of experiments with moderate guidance.
Independently execute experiments with good quality, including sample preparation from FFPE tissue samples, real-time PCR and cell culture.
Pay attention to technical details and conduct effective troubleshooting when needed.
Maintain detailed experiment records in lab notebooks in compliance with company guidelines.
Monitor and order lab supplies.
Participate in general lab maintenance efforts.
Create technical documentation including protocols and technical reports.
Compliance to applicable US and international Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93/42/EEC, 98/79 EC, and the requirements of the company Quality Management System.
BS/MS degree in Life sciences (such as Molecular and Cell Biology, Genetics and Biochemistry) with 6+ years of lab experience including 2+ years of IVD development experience.
Hands-on experience on molecular biology techniques such as nucleic acid sample preparation, PCR, RT-PCR, real-time PCR and melting curve analysis is required.
Good technical writing skill is required.
Familiarity with GLP environment, documentation and quality system is highly desirable.
General knowledge on basic statistics is required. Understanding the principles of DOE and Design for Six Sigma and hands-on experience with statistics tools (JMP and/or MiniTab) are a plus.
Excellent communication, planning and organization skills are essential.
Ability to work and collaborate effectively in a dynamic environment with a team of diverse disciplines is required.
High integrity, professional and personal ethics are required.
NO sponsorship, NO relocation. US based candidates only, please
Qualified candidates, please send current Word resume to: email@example.com for immediate consideration
CareerBuilder - 13 months ago