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Microbiology Manager

Arevna

Job Title: Director - Microbiology & Quality Control Location: South Carolina, USA About the Opportunity: We are partnering with a leading Contract Development & Manufacturing Organization (CDMO) in South Carolina to find a Senior Manager/Director of Microbiology & QC. This is a high-impact leadership role overseeing QC Microbiology, Environmental Monitoring, and Sterility Assurance operations. Key Responsibilities Lead and develop QC Microbiology teams, fostering engagement, coaching, and career growth. Oversee sterility testing, bioburden, endotoxin, microbial identification, and other microbiological assays. Ensure compliance with cGMP, USP, EP, JP, and regulatory inspection readiness (FDA, EMA, PMDA). Drive continuous improvement initiatives in laboratory operations and processes. Collaborate with R&D, Manufacturing, QA, and Project Management to support method transfers and QC strategy. Review and approve SOPs, protocols, deviations, CAPAs, investigations, and analytical data. Contribute to budgeting, resource planning, and strategic initiatives for QC operations. Qualifications Advanced degree in Microbiology, Biotechnology, Biology, or related field preferred. 10+ years of progressive experience in QC Microbiology, sterility assurance, and regulatory compliance within biologics or pharmaceutical/CDMO environments. Proven leadership experience managing teams and laboratory operations. Strong communication, problem‑solving, and strategic planning skills. Why Apply Lead microbiology and QC operations at a growing, innovative CDMO. Work on cutting‑edge biologic products in a collaborative environment. Competitive compensation and benefits. Seniority level Director Employment type Full-time Job function Management and Quality Assurance Industries Pharmaceutical Manufacturing and Biotechnology Research #J-18808-Ljbffr

Vacancy posted 1 day ago
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