Microbiologist
Core
Provides technical leadership in environmental monitoring, contamination control, and cleanroom process design within a GMP-compliant radioconjugate manufacturing facility.
Role type
Senior Microbiologist (Environmental Monitoring & Contamination Control)
Builds
GMP-compliant radioconjugate manufacturing processes and cleanroom environments
Domain
Pharmaceutical manufacturing / Oncology / Radiopharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing environment)
Required skills
Environmental monitoring, contamination control, cleanroom operations, GMP compliance, EU Annex 1, root cause analysis, CAPA, bioburden control, change control, risk assessment, procedure authoring
Preferred skills
Radiopharmaceutical environment experience
Technologies
Isolators, hot cells, PPE, radiation safety protocols
Responsibilities
Design and maintain environmental monitoring programs for classified manufacturing areas; assess microbiological risks from environmental excursions; lead EMPQ activities for cleanrooms and utilities; investigate contamination events and deviations; provide technical guidance on bioburden control strategies; author and revise GMP procedures; support change controls and risk assessments; train operations and quality teams.
Seniority
Senior, hands-on IC