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 ScientistsManaging day-to-day QC Microbiology laboratory operationsOverseeing environmental monitoring programs for cleanrooms and manufacturing facilitiesSupporting utilities monitoring including water systems, compressed gases, and clean steamLeading sterility testing, bioburden testing, endotoxin testing, and microbial identification activitiesDriving microbiology method qualification, validation, verification, and transfer programsReviewing microbiological data, protocols, reports, and investigations to ensure scientific integrity and GMP complianceLeading contamination investigations, deviations, OOS, and environmental monitoring excursionsPerforming root cause analysis and implementing effective CAPAsServing as the QC Microbiology SME during client audits, regulatory inspections, and technical meetingsPartnering with Manufacturing, Validation, Facilities, and QA teams to maintain robust contamination control strategiesDriving continuous improvement initiatives across microbiology operations, data integrity, and laboratory efficiencyWhat we're looking for:Bachelor's, Master's, or PhD in Microbiology, Biological Sciences, Biotechnology, or a related disciplineExtensive experience within GMP-regulated biopharmaceutical, biologics, cell therapy, gene therapy, or CDMO environmentsPrevious supervisory or people management experience within a QC Microbiology laboratoryStrong expertise in environmental monitoring, sterility testing, endotoxin testing, bioburden testing, and microbial identificationExperience supporting aseptic manufacturing operations and contamination control programsKnowledge of microbiological method validation, verification, and technology transferStrong understanding of FDA, EMA, USP, EU Annex 1, and GMP requirementsProven experience leading microbiology investigations, deviations, and CAPA activitiesAbility to mentor, develop, and build high-performing teamsStrong communication skills with experience supporting clients, auditors, and regulatory inspectionsThis 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.