Duties:
- Work closely with internal and external collaborators and cross-functional teams to validate standardized analytical methods for testing key reagents, including raw materials, buffers and solutions, specimens, controls, formulated reagents, and/or reference materials (RNA and/or DNA)
- Conduct routine testing to ensure compliance to quality standards
- Support technology-transfer for all analytical methods to pilot plant and manufacturing operations (QC) for QC release testing
- Work with Quality team on all documentation
Skills:
- Technical expertise in conducting analytical testing using PCR, RT-PCR, HPLC, CE, gel electrophoresis (including chip-based methods such as Agilent Bioanalyzer), Mass Spec, fluorescence and/or absorbance spectrophotometers, and other analytical methods in an industrial environment is required, preferably in a molecular diagnostic product development setting
- Knowledge of biochemistry and analytical chemistry is essential
- Experience in QC release testing and/or technology transfer to manufacturing, preferably in a diagnostic product development setting preferred. Knowledge of and experience in quality and regulatory requirements under which molecular diagnostic products are developed, commercialized and supported (for example 510k or PMA applications, GLP, GCP, and GMP, etc.)
- Knowledge of FDA and CLIA regulations are important to understand. Hands-on experience in analytical QC testing of DNA/RNA controls and/or primers and probes for molecular diagnostic product development highly desirable
Education:
A Bachelor's degree with 7+ years of industry experience or Master's degree with 4+ years of industry experience in the area of QC.
Candidates must live local and be a US Citizen or Green Card Holder
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.
Commonwealth Sciences, Inc.