Microbiology Manager

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.

• 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.

• 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.

• Lead microbiology and QC operations at a growing, innovative CDMO.
• Work on cutting‑edge biologic products in a collaborative environment.
• Competitive compensation and benefits.

Director

Full-time

Management and Quality Assurance

Pharmaceutical Manufacturing and Biotechnology Research