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
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