Microbiology Group Leader
Core
Lead microbiology testing operations ensuring GMP/GLP compliance, managing staff, and driving operational improvements for client service requirements.
Role type
Senior IC Microbiology Group Leader
Builds
Microbial limits testing, sterility testing, endotoxin testing, and environmental monitoring services for pharma and life sciences clients.
Domain
Life Sciences / Pharmaceutical Testing / Quality Assurance
Deliverable
Production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Microbial limits testing (USP <61>, <62>, <60>), Antimicrobial effectiveness testing (USP <51>), Sterility testing (USP <71>), Bacterial endotoxin testing (USP <85>), Aseptic techniques, Microbial identification, Regulatory compliance (USP, ICH, Ph. Eur.), Laboratory investigations, Audit response support, Team supervision, Operational improvement, Change management, Financial acumen
Preferred skills
Mentoring technical staff, Leading complex technical audits, Driving LEAN initiatives, Instrumental/analytical theory expertise
Technologies
USP <61>, <62>, <60>, <51>, <71>, <85>, Time-entry systems
Responsibilities
Ensure quality policy program implementation and maintenance, Supervise and coach team members, Coordinate workflow and perform daily monitoring, Conduct performance reviews and succession planning, Address performance issues and foster team morale, Initiate and drive new LEAN initiatives, Support audit responses and complex investigations
Seniority
Senior, hands-on IC with leadership responsibilities