Scientist II Job

SCIENTIST II needed for a CONTRACT opportunity with Yoh's client located in CAMBRIDGE, MA.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Cancer and genetic disorder
- NAT assay development
- Molecular assay

WHAT YOU'LL BE DOING:

- Work with the development team on NAT assays/technology platforms/reagent development through various stages of product development under design control process for all nuclear acid-based IVD products.
- Independently design and perform experiments and studies; develop, introduce and implement technical methodologies and techniques; Work on experiment data collection, data analysis and summary report.
- Use IVD product development tools (such as DOE and DFSS) and successful develop the robust NAT-based IVD diagnostics tests within defined timelines.
- Interpret study results, evaluates data and draws relevant conclusions. Present scientific/technical work at internal/external meetings or recognized achievements in the development of new procedures.
- Maintain very good understanding of relevant technologies/principles/protocols in own discipline and closely related areas. Communicates knowledge obtained from external sources to project team.
- Identify complex problems (eg overall raw data quality, inconsistency of results, appropriateness of study design/approach/technology, scientific approaches to address demanding issues) and devise creative and workable solutions.
- Publishes internally and/or externally as main contributor; patent applications; re-views current literature in own discipline and closely related areas.
- Create technical documentation including protocols, SOPs, and technical reports. Follow Good Laboratory and Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection.
- Supervise junior scientists and/or technicians, where applicable.
- 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 CDx Quality Management System.

WHAT YOU NEED TO BRING TO THE TABLE:

- MS or PhD in Biochemistry, Molecular Biology or a related discipline with three (3+) years post-graduate research and development experience in cancer and genetic disorder.
- At least three (3) years industrial experience for NAT assay development under design control process for IVD product.
- In-depth knowledge of nuclear acid biochemistry and three (3) years of molecular assay and sample processing development experiences in IVD industry.
- Strong background in high-sensitivity nucleic acid amplification and detection coupled with automated sample processing platforms and technologies, extensive experience in the development of DNA/RNA based assays to detect genetic variation and mutation.
- Hands-on experience on nucleic acid sample preparation, gene expression profiling, Real Time PCR, digital PCR, next generation sequencing, mutation detection, and cell culture.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Proven scientific achievements and track record for innovation; hands on experiences with molecular assay development, statistics tools (Minitab or JMP), and bioinformatics tools are desirable.
- Knowledge of DFSS, understanding the principles of DOE and working experience and knowledge of cGMP practices, documentations and quality control system are highly desirable.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC

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