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Microbiologist - Pharmaceutical Method Development Job Description The microbiologist develops, evaluates, and validates compendial microbiology methods to support new product transfers to the site, including sterile injections, non-sterile liquid suspensions, and solid oral dose pharmaceutical products. The position collaborates closely with the microbiology QC team, project teams, and external customers as a technical subject matter expert, while working under the guidance of analytical development or quality control leadership. Responsibilities + Perform method feasibility, development, and validation for compendial microbiology methods supporting new product transfers to the site. + Develop and validate microbiological methods for multiple product types, including sterile injection products, non-sterile liquid suspensions, and solid oral dose veterinary pharmaceutical drug products, as well as associated active pharmaceutical ingredients (APIs) and raw materials. + Author, execute, and complete method development and validation protocols, including writing and reviewing validation reports in alignment with established templates and standard operating procedures (SOPs). + Conduct sterility testing in accordance with USP , including method validation for liquid injection products and sterile suspensions, with preferred use of isolator-based testing where applicable. + Perform endotoxin testing in accordance with USP , including method validation for liquid injection products, raw materials, and sterile suspensions using kinetic chromogenic or turbidimetric methods and associated instrumentation. + Execute Microbial Limits Testing in accordance with USP and , including method validation for non-sterile liquids, pastes, suspensions, raw materials (solids and liquids), and bulk injection solutions. + Conduct subvisible particulate testing per USP using light obscuration and microscopic methods to ensure compliance with particulate limits. + Perform media growth promotion testing and microbial identification to confirm suitability of culture media and accurately identify microorganisms as required. + Follow cGMP requirements and

FDA 21 CFR 210/211

regulations in all laboratory operations, documentation, and quality control activities. + Collaborate closely with the microbiology QC team and cross-functional project teams to support timelines, resolve technical issues, and ensure successful method transfer and implementatio To view full details and how to apply, please login or create a Job Seeker account