Senior Manager Microbiology (Sterile Injectable Facility)

Role & responsibilities

• Lead end-to-end Microbiology Laboratory and Process Microbiology operations.
• Manage Environmental Monitoring (EM), personnel monitoring, water monitoring, sterility testing, BET and microbiological testing.
• Drive Contamination Control Strategy (CCS) and microbiological risk management across sterile operations.
• Lead investigations related to EM excursions, deviations, OOS/OOT, failures and CAPA.
• Ensure readiness and represent Microbiology during USFDA, EU-GMP and customer/regulatory audits.
• Review/approve SOPs, protocols, validation/qualification documents, investigations and microbiology reports.
• Oversee Media Fill/APS, method validation, area qualification and microbiological risk assessments.
• Lead implementation and effective utilization of LIMS, EM and other digital systems.
• Manage, mentor and develop a 60+ member Microbiology team, including manpower planning, training and competency development.
• Collaborate with QA, Production, QC, Engineering, Validation and Regulatory teams for compliance and operational excellence.
• Drive continuous improvement, laboratory efficiency, digitalization and microbiology best practices.

Preferred candidate profile