QC Scientist II, Microbiology

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at . The Role The Scientist II QC Microbiology serves as senior technical subject matter expert responsible for overseeing microbiological testing programs supporting GMP operations. This role provides technical leadership across QC Microbiology and Manufacturing by ensuring effective microbiological testing, mentoring laboratory staff, supporting quality systems and delivering aseptic technique training to maintain compliance with GMP and contamination control requirements. 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. * Track and support quality system activities including deviations, investigations, CAPAs, Change Control and trending associated with QC microbiology operations. * 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. * Collaborate cross-functionally with Manufacturing, QA , Facilities and other teams to support manufacturing operations and process improvements. * Support regulatory inspections, audits and responses by providing technical justification and documentation.

Created: 2026-04-19