As a Senior Scientist within the Reagent Manufacturing and Quality team, you will be an integral part of Genomic Health's Operations group, with responsibility for the development, validation, and transfer of new manufacturing processes and quality control test methods, both for new products and our existing genomic tests. In this role, you will lead and participate in cross functional teams contributing to the development of IVD and LDT products under design control, in accordance with ISO 13485 and Good Manufacturing and Laboratory Practices (GMP/GLP). You will participate in requirements definition, risk analysis, reagent and QC method development, manufacturing development and scale-up, optimization, troubleshooting, and verification and validation activities related to manufacturing and quality control testing.
The high complexity nature of the work demands in-depth understanding of reagent and consumable development, manufacturing, and analytical and functional test methods for quality control, and strong working knowledge of ISO 13485 and other applicable quality system requirements. This position requires excellent leadership, collaboration, written and verbal communication skills, attention to detail, ability to multi-task, and flexibility to adapt to changes in priority and schedules are essential.
- Lead and participate in efforts to support the development of IVD products under design control in conformance with ISO 13485(2016).
- Partner with Genomic Sciences, Biostatistics, and other functions in the development and use of appropriate test methods for characterizing the composition, functional performance, and stability of reagents and consumables required for the development and launch of new products.
- Collaborate closely with colleagues in Quality, Supply Chain Management, Biostatistics, Process Engineering, R&D, and other functions to facilitate effective, efficient process transfer and ensure supplier and OEM vendor quality.
- Create required documents such as reagent manufacturing and quality control testing procedures, incoming material specifications, and performance verifications, and protocols and reports for studies required to transfer reagent products into production (e.g. stability, specification-setting, manufacturing process optimization, and related studies).
- Assist in or lead investigation and resolution of reagent / consumable-related issues, including assessment of impact, root cause identification, and appropriate corrective and preventive action.
- Ensure consistent compliance with applicable regulations and quality-related best practices in development, validation, use, and documentation of assay development, analytical and functional quality control test methods for reagent lot qualification, stability studies, and related activities.
- Train and mentor team members in IVD product development and manufacturing transfer
- Additional responsibilities as assigned.
- Bachelor's degree in a molecular biology, biochemistry, chemistry, or an associated relevant field with 10+ years relevant industrial experience. Advanced degree preferred.
- Strong background in biochemistry and molecular biology methods with experience in reagent development, manufacturing, and QC for nucleic acid isolation, purification and quantitation, qPCR, and next generation sequencing assays.
- A track record of success in scale up and manufacturing transfer projects for new CE-IVD molecular diagnostic products under ISO 13485 and/or FDA Quality System Regulations (QSR) is required
- Highly motivated, detail oriented individual with consistent record in solving technical problems effectively and efficiently.
- Superb communication, collaboration, and leadership skills are required
- Ability to maintain open, constructive communication and collaboration with colleagues, management, and suppliers.
- Ability to prioritize and adapt to changing priorities while maintaining a high standard on quality.
- Ability to work in a fast paced, multidisciplinary and dynamic environment and capable of handling multiple activities simultaneously.