Senior Microbiologist

Senior MicrobiologistThe Senior Microbiologist serves as a technical leader within the Microbiology laboratory, responsible for advanced microbiological testing, complex troubleshooting, and oversight of laboratory investigations. This role drives scientific rigor and compliance by leading root cause investigations, owning CAPAs, and executing continuous improvement initiatives.The Senior Microbiologist is a subject matter expert (SME) in Environmental Monitoring (EM), Water for Injection (WFI), and product-related microbiological testing, and plays a key role in mentoring and developing laboratory personnel while supporting cGMP sterile manufacturing operations.Job ResponsibilitiesTechnical Expertise & Laboratory Leadership Serve as a subject matter expert (SME) for microbiological methods, testing techniques, and equipment.Maintain training and provide technical guidance to Microbiologists on all microbiological testing including product and water bioburden, endotoxin testing, TOC and Conductivity, sterility, and organism identification.Lead and execute complex microbiological testing, method troubleshooting, and atypical result evaluations.Evaluate and improve microbiological methods for robustness, compliance, and efficiency.Support method validations, verifications, and transfers.Investigations, CAPAs, & Quality Systems Lead and own microbiological deviation and laboratory investigations, including thorough root cause analysis.Author and drive corrective and preventative actions (CAPA) to completion against defined timelines, ensuring effectiveness and sustainabilityAct as primary microbiology representative in investigations impacting manufacturing, utilities, or product qualityExecute microbiological change controls for laboratory and manufacturing processes with technical accuracyProcess Improvement & Continuous Improvement Lead process improvement initiatives to enhance laboratory efficiency, compliance, and audit readinessDrive risk-based decision making for prioritizationMentorship & Team Development Provide bench-side mentorship, coaching, and technical training to MicrobiologistsDevelop training materials and ensure effective onboarding and ongoing competency developmentAct as a resource for troubleshooting and scientific problem-solving for the teamRegulatory Inspections & Audit Readiness Serve as the primary microbiology representative during regulatory inspectionsResponsible for ensuring inspection readinessMaintain effective communication with inspectorsDrive actions for successful resolution of audit observations or improvements identified.This position may be involved with the transportation and handling of hazardous waste; must successfully complete Resource Conservation Recovery Act (RCRA) training within 1 year of hire, and annually thereafter.Experience RequirementsMinimum of 5-8 years of related laboratory experience, academic or otherwiseKnowledge of aseptic techniquesKnowledge of cGMPExperience in activities pertaining to aseptic manufacturing and knowledge of how to maintain an aseptic environmentDemonstrated experience leading investigations, CAPAs, and root cause analysisStrong leadership, mentoring, and coaching skillsAbility to multi-task, work under pressure with time constraintsMust be flexible and able to adapt to changes in task priorityExcellent communication skills and ability to work independently to complete tasksEducation RequirementsBachelor of Science (BS) Degree in Microbiology, Biology, or related Life Sciences.