- Wexford-Wexford
- 5+ years
Lead the design, development, and optimization of diagnostic assay reagent kits and consumables for LC-MS/MS in vitro diagnostic products.
Responsibilities
- Provide scientific and technical leadership for the design and development of LC-MS/MS diagnostic assays, reagent kits and associated consumables from feasibility through product launch.
- Lead the technical execution of complex assay development projects, translating customer, product and regulatory requirements into robust assay designs, performance requirements and analytical specifications.
- Develop and optimize assay methodologies, reagent formulations and experimental strategies to ensure products meet defined performance, quality, robustness and manufacturability requirements.
- Define appropriate analytical performance, verification and validation strategies, ensuring that studies are scientifically sound, appropriately risk-based and compliant with applicable regulatory requirements and technical guidelines.
- Lead technical feasibility activities, including assessment of assay concepts, prototypes, materials, analytical performance and stability requirements.
Requirements
- A degree in a relevant scientific subject with a strong chemistry component or related field is required. An advanced degree (PhD, MSc) is desirable.