Microbiologist

Job Description:Responsibilities:Serve as subject matter expert for microbiological testing programs including environmental monitoring, sterility, endotoxin, mycoplasma, microbial identification, and contamination control.Support QC Microbiology Senior Manager in oversight of laboratory operations, technical initiatives, and microbiological program execution.Develop and deliver aseptic technique and contamination control training for manufacturing and QC personnel to maintain compliance with GMP and cleanroom practices.Review and approve microbiological data, protocols, quarterly reports , SOPs and other technical documentation.Lead data trending and interpretation of environmental monitoring and microbiological data to identify risks and support contamination control strategy.Provide technical leadership and mentorship to microbiologists and junior scientist within QC microbiology laboratory.Author and review SOPs, protocols, validation reports, investigation reports and technical documents in accordance with GMP requirements.Lead or support method qualification, validation, and technology implementation for microbiological assays.Support regulatory inspections, audits and responses by providing technical justification and documentation.Required QualificationsBS degree in Biology/Microbiology with 10+ years or M.S. with 6+ years of relevant experience in a GMP QC microbiology laboratory.Demonstrated advanced expertise in microbiological testing including environmental monitoring, bioburden, endotoxin, sterility, mycoplasma and microbial identification.Experience supporting aseptic manufacturing environments and cleanroom operations.Strong knowledge of cGMP regulations and microbiological control strategies.Strong interpersonal skills, highly collaborative within a multi-disciplinary team and contributes to a supportive and positive work environment.$50.00 - $56.00 / hrLI23LILive24