Principal Assay Development Scientist

The Assay Development function is responsible for the development of in vitro diagnostic (IVD) assays throughout all stages of the product lifecycle, including feasibility, development, verification, validation and Design Transfer. The team owns assay requirements, analytical specifications, preliminary performance characterization, and the assay-analyzer interface, ensuring robust, high-quality solutions that meet customer, regulatory, and business requirements.

• 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.
• Provide scientific leadership in the investigation and resolution of complex technical issues, applying structured experimental design, statistical analysis and scientific problem solving to establish root cause and appropriate technical solutions.
• Lead Design Transfer activities include process validation and scale up.
• Lead or provide technical input into design reviews, risk assessments and FMEAs, ensuring product and process risks are identified, understood and appropriately controlled throughout development.
• Work closely with Product Management and Commercial teams to translate customer and market needs into scientifically appropriate product requirements and assay performance expectations.
• Collaborate closely with Clinical Affairs, Regulatory Affairs , Quality to develop appropriate evidence and documentation to support clinical studies, regulatory submissions and design control activities.
• Collaborate with Operations during design transfer and scale-up, providing assay expertise and ensuring that critical product characteristics and scientific knowledge are effectively transferred into manufacturing.
• Apply statistical tools and experimental design approaches to assay optimization, characterization, verification and validation, including evaluation of variability and product robustness.
• Maintain awareness of developments in LC-MS/MS diagnostics, analytical technologies, scientific literature and competitor products to identify opportunities for assay and technology advancement.
• Act as a technical mentor and subject-matter expert for scientists within Assay Development, developing scientific capability through coaching, experimental review and knowledge sharing.
• Contribute to project and portfolio reviews by clearly communicating technical progress, risks, decisions and recommendations to Assay Development leadership and cross-functional stakeholders.
• Ensure all development activities are performed in accordance with the Quality Management System, applicable regulatory requirements and Environmental, Health and Safety procedures.