New 
Senior Operations Scientist
 Spectraforce Technologies | |
 United States, Maine, Scarborough | |
 Apr 03, 2026 | |
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Job Title: Senior Operations Scientist
Location: Scarborough, Maine; 04074 Duration: 06 months MAIN PURPOSE OF THE ROLE Individual contributor with comprehensive knowledge in reagents manufacturing processes. Ability to plan and execute highly complex or specialized projects. Carries out complex/critical fundamental or applied research in the biological or physical sciences or in mathematics, requiring appreciable originality and ingenuity. MAIN RESPONSIBILITIES * Draft validation protocols, execute validations, and draft validation reports for reagents manufacturing processes (i.e. mixing, pooling, cleaning) - operational qualification (OQ), test method validation (TMV), performance qualification (PQ), and process validation (PV) are all within scope * Design of Experiments (DOE) involving different reagent combinations, concentrations, and operating conditions - coordinating execution, documenting results, and presenting findings * Develop and maintain data tracking sheets for experiment results, critical process parameter (CPP) operating ranges, critical quality attribute (CQA) results across manufacturing events * Utilize quality management system (QMS) for documentation of study results, complying to site design control and validation procedures * Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, risk assessments, and procedures and other technical documents to insure compliant, efficient and safe processes. * Use design for manufacturability (DFM) principles to make recommendations for design improvements * Work cross-functionally with R&D and QA to develop study plans and execute process & design improvements Required Qualifications * Bachelor's degree (BS) in Biology, Chemistry, Engineering or similar scientific/technical discipline * 6+ years of experience in a scientific/technical role in Operations or R&D * Proficient with statistical analysis software (Minitab or JMP preferred) Preferred Qualifications * Master's degree in Biology, Chemistry, Engineering or similar scientific/technical discipline * Exposure to diagnostics and immunoassay technologies * Experience with data science/data visualization highly preferred * Familiarity with basic project management tools and principles (i.e. Smartsheet, Microsoft Project) | |