The opportunity
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…
What you'll do
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
What they're looking for
- 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
- 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
