Senior Operations Scientist

Position Summary The Senior Operations Scientist is an individual contributor with advanced expertise in reagent manufacturing processes. This role is responsible for planning and executing highly complex validation activities, designing experiments, analyzing data, and supporting continuous process improvements. The ideal candidate demonstrates strong technical capability, scientific rigor, and the ability to work cross-functionally to improve manufacturing quality and efficiency. Key Responsibilities Validation & Process Qualification • Develop validation protocols, execute studies, and prepare comprehensive validation reports. • Lead validation activities including Operational Qualification (OQ), Test Method Validation (TMV), Performance Qualification (PQ), and Process Validation (PV). • Validate mixing, pooling, cleaning, and other reagent manufacturing processes. Experimental Design & Data Analysis • Plan and perform Design of Experiments (DOE) to evaluate reagent combinations, concentrations, and operating conditions. • Coordinate experiment execution, document results, and present findings to stakeholders. • Build and maintain data tracking tools for experiment results, Critical Process Parameters (CPPs), and Critical Quality Attributes (CQAs). • Utilize Minitab, JMP, or similar tools for statistical analysis. Documentation & Quality Systems • Prepare and revise manufacturing documentation, including SOPs, specifications, safety instructions, and risk assessments. • Use Quality Management Systems (QMS) to document validation studies and ensure compliance with design control and site procedures. Process & Design Improvement • Apply Design for Manufacturability (DFM) principles to recommend design and process improvements. • Collaborate with R&D and Quality Assurance teams to support implementation of process changes and continuous improvements. Required Qualifications • Bachelor’s degree in Biology, Chemistry, Engineering, or related scientific/technical field. • Minimum of 6 years experience in a scientific or technical role within Operations or R&D. • Proficiency with statistical analysis software such as Minitab or JMP. Preferred Qualifications • Master’s degree in Biology, Chemistry, Engineering, or related field. • Experience in diagnostics or immunoassay technologies. • Strong background in data science or data visualization. • Familiarity with project management tools such as Smartsheet or Microsoft Project.