Microbiology Manager

BioTalent; Fort Lauderdale (FL); Vor Ort; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

BioTalent is partnering with a growing biologics CDMO to hire a QC Manager, Microbiology, responsible for leading microbiological quality control activities across development and manufacturing programs.

This hands-on leadership role combines technical microbiology expertise with people management to oversee QC operations, environmental monitoring, and CAPA activities, while ensuring GMP readiness for audits and client programs.

Qualifikationen

• Bachelor's, Master's, or PhD in Microbiology, Biological Sciences, Biotechnology, or related discipline.
• Experience in GMP-regulated biopharmaceutical, biologics, cell therapy, gene therapy, or CDMO environments.
• Previous supervisory or people management experience in a QC Microbiology lab.

Aufgaben

• Lead a team of Microbiology Analysts and Scientists.
• Oversee day-to-day QC Microbiology operations and environmental monitoring programs.
• Support sterile/aseptic processes, sterility and bioburden testing.
• Drive method qualification, validation, verification and technology transfer.
• Review data, protocols, reports, and investigations to ensure GMP compliance.
• Act as QC Microbiology SME during client audits and regulatory inspections.
• Collaborate with Manufacturing, QA, Validation, Facilities and MSAT to maintain contamination control strategies.

Kenntnisse

Team leadership

Environmental monitoring

GMP compliance

Microbiology testing

CAPA investigations

Communication with clients/auditors

Ausbildung

Bachelor's/Master's/PhD in Microbiology

Jobbeschreibung

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.