Scientist II

Job Description

Job Summary:

• The candidate will have strong experimental skills, a broad understanding of molecular biology, and an understanding of regulated product development (CE-IVD and IVD).

Duties and Responsibilities:

• Perform experiments to improve and develop nucleic acid purification reagents and automated workflows for variety of sample types including Whole blood, Plasma, FFPE and Urine.
• Perform laboratory bench work with focus on sample preparation and sequencing to support development of targeted sequencing assays.
• Participate in various studies through analytical validation and clinical validation phases of product development.
• Perform some experimental design, basic data analysis, interpretation, and data summarization to help guide product development for new product introductions, sustaining programs and or CDx programs.
• Prioritize daily activities to ensure timely completion of tasks and projects.
• Work in close collaboration with cross functional teams including bioinformatics, engineering, Product Management, Manufacturing, and Regulatory affairs to deliver high quality results.
• Maintain accurate and detailed lab notebooks and appropriate documentation
• Support On-Market product and manufacturing troubleshooting with strong “customer-first” mind set.
• Follow ISO 9001 and 13485 requirements.

Education and Experience:

• BS with minimum 3 years relevant experience.
• MS in Biology/Molecular Biology or related field with minimum 1 year relevant experience
• Experience in IVD product development nice to have.
• Experience in automated platforms such as Genexus or similar, and Liquid handers is a plus.
• Possess understanding and have related experience in basic chemistry and molecular biology techniques (including Nucleic acid extractions, quantitation and characterization, PCR techniques, and Reagent/buffer preparation).

Knowledge, Skills and Abilities:

• You should have a solid knowledge of the next generation sequencing as demonstrated by your publication history or industry experience.
• In depth understanding of genomics and cancer biology.
• Familiarity with regulatory feedback or guidance documents to support study designs.
• Effective communication skills, especially for presenting scientific results, keeping records and working collaboratively in a team of scientists are necessary.
• Must have the ability to take initiatives and operate with some supervision.