Title: Senior Operations Scientist Location: Scarborough, Maine Duration: 6 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
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