Microbiology Department Project Lead
Core
Technical leader for microbiology program governance, laboratory projects, and quality system improvements at a sterile pharmaceutical manufacturing site.
Role type
Senior IC microbiology project lead
Builds
Microbiology testing programs, environmental monitoring systems, and quality compliance frameworks
Domain
Pharmaceutical manufacturing / Sterile production / GMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiology testing oversight, Environmental monitoring, Contamination control, GMP documentation, Method qualification and validation, Investigation and deviation management, CAPA management, Project management, Cross-functional coordination, Risk assessment, Regulatory compliance monitoring, Data trend analysis, Change control management
Preferred skills
Strategic laboratory initiative leadership, Mentoring laboratory personnel, Scientific excellence advocacy
Technologies
Office 365
Responsibilities
Provide scientific oversight for microbiological testing and environmental monitoring; Lead microbiology projects from initiation to implementation; Own and coordinate microbiology change controls; Author and approve microbiology procedures and technical documents; Lead method qualification and validation activities; Review and approve investigations, deviations, and CAPAs; Partner with cross-functional teams for product changes and new introductions; Assess microbiological risks for process and facility changes; Drive continuous improvement for laboratory efficiency and compliance; Monitor regulatory expectations and industry standards; Support regulatory inspections and audits; Analyze microbiological data to identify risks and improve process understanding.
Seniority
Senior, hands-on IC with strategic oversight