QC Microbiology Leader — Biologics (GMP)

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 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.