Sr. Scientist (W2 Only) in Scarborough, ME

Job Title – Senior Operations Scientist (Validation & Manufacturing Sciences) Job Location Type – In Person Location – Scarborough, ME 04074 Job Type – 6-Month Contract (Strong Potential for Extension or Full-Time Conversion) Shift Schedule – Monday–Friday | 8:00 AM – 5:00 PM About The Role We are seeking a technically strong Senior Operations Scientist to support reagent manufacturing operations in a hands-on laboratory environment. This role is heavily focused on process validation, scientific study execution, and data-driven manufacturing support. The ideal candidate will bring deep validation expertise, strong statistical analysis skills, and the ability to independently design, execute, and document scientific studies within a regulated environment. This is a high-impact role supporting manufacturing performance, compliance, and continuous improvement initiatives. Key Responsibilities • Process & Validation Leadership (Primary Focus) • Draft, execute, and manage validation protocols for reagent manufacturing processes, including mixing, pooling, and cleaning operations • Lead OQ, TMV, PQ, and Process Validation (PV) activities • Evaluate chemical mixing processes and assess solution performance • Ensure compliance with validation lifecycle requirements and design control procedures • Drive best practices in contamination control and laboratory operations • Data Management & Scientific Analysis • Collect, synthesize, and interpret large datasets from manufacturing events • Monitor and analyze Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) • Develop dashboards and data visualizations to support operational decision-making • Apply statistical tools such as Minitab or JMP for trend analysis, capability studies, and root-cause investigation • Study Design & Technical Documentation • Design detailed experimental plans and author comprehensive study protocols • Execute validation and investigative studies independently • Interpret findings and prepare formal validation reports • Author and revise SOPs, risk assessments, manufacturing documentation, and technical specifications • Utilize Quality Management Systems (QMS) to ensure documentation accuracy and regulatory compliance Required Qualifications • Bachelor’s degree in Biology, Chemistry, Engineering, or related scientific discipline • 6+ years of experience in Operations, Manufacturing Sciences, or R&D within a scientific or regulated environment • Strong hands-on laboratory experience, particularly with reagents and fluid handling processes • Demonstrated experience leading process validation activities • Proficiency in statistical analysis software (Minitab or JMP preferred) • Ability to independently manage projects, interpret data, and drive validation strategy Preferred Qualifications • Experience in diagnostics, immunoassay technologies, or amino assays • Data science or advanced data visualization experience • Master’s degree in a related scientific discipline • Familiarity with project management tools such as Smartsheet or MS Project