Location/Division Specific Information
Pleasanton, CA | GSD Clinical
How will you make an impact?
The Genetic Sequencing Division is seeking an experienced and highly motivated Development Scientist to work on a team developing qPCR based microbial detection applications for regulated markets. The candidate will have strong experimental skills, a broad understanding of molecular biology and/or biotechnology, and an understanding of regulated product development (CE-IVD or US IVD). The ability to collaborate effectively as part of a cross functional team including R&D, Software, Product Managers, Manufacturing and external partners is essential.
What will you do?
- Execute Research and Development activities through all phases of product development, manufacturing transfer, as well as transfer between manufacturing sites.
- Perform clinical sample extraction, qPCR assay and experiment optimization, experiments in molecular biology laboratories (including a BSL2 lab), including operation of liquid handling systems, on a regular basis.
- Optimize product and process using statistical tools (DOE, MSA, etc.)
- Develop testing protocols; prepare project reports, and present study designs and results in PowerPoint to the project team.
- Interact cross functionally. Transfer new qPCR product and process to Manufacturing.
- Support On-Market product and manufacturing troubleshooting with strong “customer-first” mind set.
- Follow regulatory compliance in ISO 9001 and 13485.
- Adapt to fast-paced environment and project priority shift effectively and efficiently.
How will you get here?
- BS Degree, 3+ years/MS Degree, 1+ years of industry experience
- Strong skills in molecular biology (including DNA, RNA and protein handling, PCR, qPCR, quantification methods)
- Regulatory and Manufacturing Experience in IVD product development, clinical genetic testing, or core laboratory facility preferred.
- Experience with methods for extraction of DNA and RNA from microbes and viruses (manual and automated sample prep methods). Candidate must have a general understanding of microbiology.
Knowledge, Skills, Abilities
- Must be tolerant to change, ready to take on new challenges and open to learning new skills
- Knowledge of basic data analysis and interpretation (proficient in Microsoft Office)
- Ability to follow molecular biology protocols and strictly adhere to all steps