Supervisor III - Microbiology

Job Description

The Microbiology Supervisor III provides senior operational leadership for the Microbiological Quality Control function, including routine microbiology testing, sterility support activities, environmental monitoring support functions, laboratory investigations, quality system records, training, and compliance execution.

This position is responsible for prioritizing departmental work, aligning personnel and laboratory resources, monitoring due dates and turnaround times, developing assigned personnel, and ensuring timely execution of laboratory and quality system commitments.

The Microbiology Supervisor III provides oversight to assigned supervisors and laboratory personnel and serves as the primary day-to-day operational leader for MQC. The role partners with the Manager, QC, Quality Assurance, Manufacturing, Validation, Engineering, Planning, and client-facing project teams to ensure laboratory activities are executed in accordance with cGMP expectations, approved procedures, data integrity requirements, and business priorities.

The Supervisor III may assume delegated Manager responsibilities as assigned.

• Provide day-to-day operational leadership for the Microbiological Quality Control function, including routine microbiology testing, sterility support activities, environmental monitoring support activities, and related quality system workstreams.
• Establish and communicate daily, weekly, and longer-range priorities based on compliance risk, product release needs, client commitments, investigation due dates, CAPA/change control commitments, and laboratory capacity.
• Allocate personnel and laboratory resources across testing, investigations, procedure revisions, training, validation support, and quality system activities to support timely completion of departmental commitments.
• Monitor turnaround time, due-date performance, workload balance, and quality system execution; proactively escalate resource constraints, compliance risks, or barriers to completion.
• Provide direct supervision, coaching, development, and performance management for assigned supervisors, and personnel.
• Oversee training compliance and qualification readiness for assigned personnel, including ensuring adequate coverage for critical microbiology methods and responsibilities.
• Provide technical and compliance guidance to supervisors and laboratory personnel during investigation of unexpected results, deviations, OOS/OOT events, laboratory events, and procedural or documentation issues.
• Review and/or approve laboratory records, analytical reports, investigations, CAPAs, change controls, procedures, protocols, reports, and related documentation in accordance with approved procedures and assigned authority.
• Maintain a state of inspection readiness through active oversight of laboratory practices, documentation, quality systems, training compliance, and procedural adherence.
• Serve as delegated back-up to the Manager, QC, for assigned responsibilities as needed.

Required

• Bachelor of Science in Microbiology, biology or related scientific discipline required; Microbiology emphasis preferred
• Minimum 8 years of pharmaceutical laboratory experience required.
• Minimum 4 years supervisory experience required.
• PMP required (or equivalent such as PgMP)
• Experience in a Contract Manufacturing Organization (CMO/CDMO).
• Exposure to commercial, technical transfer, development, or lifecycle programs.
• Experience partnering with senior leadership and client-facing teams.