Senior Scientist, R&D Design Transfer & Product Development

POSITION SUMMARY: The Senior Design Transfer Scientist will lead and support the transition of In Vitro Diagnostic (IVD) Next-Generation Sequencing (NGS) assays from R&D to Operations. This role is responsible for planning, executing, and documenting all design transfer activities while ensuring strict compliance with regulatory and quality standards. The ideal candidate will balance hands-on laboratory work, data analysis, and documentation. As a cross-functional collaborator, you will interface with multiple functional groups to drive project deliverables to completion in a dynamic, fast-paced environment. PRIMARY RESPONSIBILITIES: • Design Transfer & Validation: Plan and execute process validations (IQ/OQ/PQ), stability studies, and study protocols; perform data analysis and author final reports • Test Method Development: Support test method development, characterization, and Test Method Validation (TMV), including the generation of manufacturing specifications • Quality & Risk Management: Lead Risk Management activities (including FMEAs) to identify and mitigate product risks; establish and maintain Design History Files (DHF) and Device Master Records (DMR) • Sustaining & Change Control: Lead change control activities to evaluate and determine the impact of design changes to on-market products • CAPA & Troubleshooting: Investigate product or process deviations, perform root cause analysis, and implement Corrective and Preventive Actions (CAPA) • Cross-Functional Collaboration: Partner with Supply Chain to establish raw material and consumable pipelines; present status updates, data, and technical proposals to cross-functional stakeholders EDUCATION & EXPERIENCE: • PhD. in Molecular Biology, Cell Biology, Biotechnology, Biochemistry, or a related scientific field with 4+ years of relevant industry experience; OR • Master’s degree in the fields above with 7+ years of relevant industry experience; OR • Bachelor’s degree in the fields above with 10+ years of relevant industry experience QUALIFICATIONS: • 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 Compensation & Total Rewards This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations. This position is also eligible for additional compensation and benefits through N