Senior Microbiology Team Lead
Core
Leading microbiology laboratory operations, investigations, and compliance for sterile manufacturing and biologics.
Role type
Senior Microbiology Team Lead (Regulatory/Quality)
Builds
Sterile manufacturing support, aseptic processing environments, and compliant laboratory data.
Domain
Pharmaceutical manufacturing / Biologics / Sterile processing
Required skills
Microbiology investigations, Contamination control, Environmental monitoring, Method validation, Equipment qualification, GMP/GLP compliance, Root cause analysis, Team leadership, Regulatory knowledge (EU GMP Annex 1, FDA), Data Integrity
Preferred skills
Isolator technology, MODA, Aseptic processing strategies
Technologies
Isolators, MODA
Responsibilities
Lead microbiology investigations (EM, sterility failures, bioburden, endotoxin), Drive root cause analysis and CAPAs, Ensure GMP/GLP/Data Integrity compliance, Oversee method validation and equipment qualification, Review and approve microbiology documentation, Support EM program improvement, Lead quality systems (SOPs, change controls), Mentor team members, Manage laboratory resources, Support audits and inspections
Seniority
Senior, hands-on IC with people management