Senior Microbiologist
Role Purpose
The Senior Microbiologist provides technical leadership and daily oversight of microbiological activities within the Quality Control department. The role ensures that products, utilities, and manufacturing environments meet required microbiological standards, supporting GMP compliance, audit readiness, and continuous improvement initiatives.
Key Responsibilities
QC Microbiology Operations
* Lead or perform routine microbiological testing according to approved methods (e.g., bioburden, microbial limits, EM, water/utility testing).
* Plan and prioritise workloads to meet production and release timelines.
* Review, verify, and approve microbiology data with a strong focus on data integrity.
* Identify and escalate OOS/OOT or atypical results promptly.
Environmental Monitoring & Contamination Control
* Oversee the site environmental monitoring (EM) programme including sampling plans, trending, and excursion management.
* Support contamination control strategy activities such as risk assessments, disinfectant strategy, and gowning/behavioural controls.
Investigations, CAPA & Change Control
* Lead microbiology‑related deviations, OOS/OOT investigations, and root cause analysis.
* Define and track CAPAs, ensuring timely closure and effectiveness checks.
* Contribute to change controls, risk assessments, and changes to methods or materials.
Method Validation, Verification & Transfers
* Design and execute method validation, verification, robustness, and transfer activities.
* Ensure alignment with pharmacopeial standards (BP, Ph. Eur., USP).
* Maintain method lifecycle control and drive continuous improvement.
Equipment & Laboratory Compliance
* Ensure microbiology equipment is qualified, calibrated, and maintained.
* Manage media (preparation/receipt, growth promotion, inventory).
* Ensure compliance with biosafety, COSHH, and laboratory safety standards.
Leadership & Training
* Provide technical supervision and coaching for microbiology staff.
* Support hiring, onboarding, and skills development within the team.
* Maintain accurate and up‑to‑date training documentation and competency records.
Quality & Regulatory Readiness
* Maintain SOPs, protocols, and controlled documents relating to microbiology.
* Support audits and regulatory inspections, providing metrics and evidence as required.
* Promote a strong quality culture and continuous improvement mindset.
Qualifications, Knowledge & Experience
* BSc or higher in Microbiology, Biological Sciences, Biomedical Science, or equivalent.
* Typically, 5+ years' experience in a GMP/regulated QC microbiology environment.
* Strong knowledge of QC microbiology methods and laboratory quality systems.
* Experience leading deviations, OOS/OOT investigations, and CAPA processes.
* Skilled in SOP writing/review and training team members