Senior Scientist, R&D Design Transfer & Product Development

Required

• Molecular Biology Experience: hands-on expertise in Next-Generation Sequencing (NGS) workflows such as DNA/RNA extraction, targeted enrichment, or whole genome library preparation and/or deep expertise with other DNA molecular biology techniques such as PCR, qPCR and multiplex PCR
• Experimental & Analytical Skills: Ability to own a study from start to finish including designing experiments, executing in the lab, analyzing data and documenting results. Must be able to perform basic statistical analysis.
• Communication: Excellent cross-functional communication and interpersonal skills, with a proven ability to present complex technical data clearly to non-technical audiences
• Execution: Exceptional time management and organizational skills, with a demonstrated ability to balance multiple priorities and drive deliverables to completion
• Knowledge of Design Controls, Quality Management Systems (QMS), and regulatory standards (FDA, ISO 13485, CLSI) within GLP/GMP environments is highly desired
• Experience authoring study plans, protocols and study reports is highly desired
• Experience with statistical software (such as JMP) is highly desired
• Prior experience in IVD product development or commercialization is preferred
• Experience in manufacturing, scale up, and Quality Control (QC) is preferred
• Experience with automated liquid handling platforms (e.g., Hamilton, Tecan) is preferred