Senior Operations Scientist

Job Title: Senior Operations ScientistLocation: Scarborough, ME - 04074Duration: 6 MonthsKey ResponsibilitiesDevelop and execute validation protocols and reports for reagent manufacturing processes including Operational Qualification (OQ), Test Method Validation (TMV), Performance Qualification (PQ), and Process Validation (PV)Design and manage Design of Experiments (DOE) involving reagent combinations, concentrations, and operating conditions; coordinate execution, analyze results, and present findings.Develop and maintain data tracking systems for experiment results, critical process parameters (CPPs), and critical quality attributes (CQAs).Utilize the Quality Management System (QMS) to document studies and ensure compliance with design control and validation procedures.Create and revise manufacturing documentation, including specifications, SOPs, safety procedures, risk assessments, and technical reports.Apply Design for Manufacturability (DFM) principles to improve product design and manufacturing efficiency.Partner with R&D, QA, and Operations teams to develop study plans, implement process improvements, and optimize manufacturing performance.Conduct complex scientific research requiring strong analytical thinking, technical expertise, and innovative problem solving.Required QualificationsBachelor's degree in Biology, Chemistry, Engineering, or a related scientific/technical discipline6+ years of experience in a scientific or technical role within Operations or R&D environmentsExperience with statistical analysis tools such as Minitab or JMPStrong analytical, documentation, and cross-functional collaboration skills.Preferred QualificationsMaster's degree in Biology, Chemistry, Engineering, or a related fieldExperience in diagnostics or immunoassay technologiesExposure to data science or data visualization toolsFamiliarity with project management tools such as Smartsheet or Microsoft Project