Microbiology Manager

BioTalent is partnered with a growing biologics CDMO looking to hire a QC Manager, Microbiology to lead microbiological quality control activities supporting biologics development and manufacturing programs.

This is a hands-on leadership role combining technical microbiology expertise with people management responsibilities. You'll oversee microbiology operations, support environmental monitoring and contamination control programs, lead investigations, and ensure the laboratory is inspection-ready while supporting client programs from development through commercial manufacturing.

You'll work closely with QA, Manufacturing, MSAT, Validation, and client teams to ensure microbiological control strategies meet GMP and regulatory requirements.

What you'll be doing:

• Leading and developing a team of Microbiology Analysts and Scientists
• Managing day-to-day QC Microbiology laboratory operations
• Overseeing environmental monitoring programs for cleanrooms and manufacturing facilities
• Supporting utilities monitoring including water systems, compressed gases, and clean steam
• Leading sterility testing, bioburden testing, endotoxin testing, and microbial identification activities
• Driving microbiology method qualification, validation, verification, and transfer programs
• Reviewing microbiological data, protocols, reports, and investigations to ensure scientific integrity and GMP compliance
• Leading contamination investigations, deviations, OOS, and environmental monitoring excursions
• Performing root cause analysis and implementing effective CAPAs
• Serving as the QC Microbiology SME during client audits, regulatory inspections, and technical meetings
• Partnering with Manufacturing, Validation, Facilities, and QA teams to maintain robust contamination control strategies
• Driving continuous improvement initiatives across microbiology operations, data integrity, and laboratory efficiency

What we're looking for:

• Bachelor's, Master's, or PhD in Microbiology, Biological Sciences, Biotechnology, or a related discipline
• Extensive experience within GMP-regulated biopharmaceutical, biologics, cell therapy, gene therapy, or CDMO environments
• Previous supervisory or people management experience within a QC Microbiology laboratory
• Strong expertise in environmental monitoring, sterility testing, endotoxin testing, bioburden testing, and microbial identification
• Experience supporting aseptic manufacturing operations and contamination control programs
• Knowledge of microbiological method validation, verification, and technology transfer
• Strong understanding of FDA, EMA, USP, EU Annex 1, and GMP requirements
• Proven experience leading microbiology investigations, deviations, and CAPA activities
• Ability to mentor, develop, and build high-performing teams
• Strong communication skills with experience supporting clients, auditors, and regulatory inspections

This role would suit a microbiology leader who enjoys balancing technical problem solving with team development and wants to play a key role in establishing and maintaining microbiological control within a growing biologics manufacturing environment.

For a confidential discussion, please apply or contact Greg Hammond at BioTalent.