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Microbiologist
Job title:Microbiologist Reporting to: Analytical Services Team Lead Department: Analytical Services No of Direct reports: 0 (on appointment) Location: Bristol Summary: eXmoor Pharma is the only integrated cell and gene therapy CDMO with over 20 years of consultancy expertise embedded across every stage of the CMC journey — from early-phase strategy to process development, GMP manufacturing and commercialisation. We provide comprehensive support across Viral Vectors, Autologous and Allogeneic Cell Therapies, and RNA technologies. This integrated model enables seamless progression from early-phase strategy through to commercial readiness.
We are looking for someone to establish and perform microbiological testing and environmental monitoring in support of pharmaceutical manufacturing operations within a GMP regulated Contract Development Manufacturing Organisation (CDMO). The role ensures product safety, quality, and regulatory compliance through accurate testing, data analysis, and adherence to validated procedures.
This is an exciting opportunity to work with eXmoor’s globally recognised team of scientists, consultants, and engineers, on a wide range of Client projects in a rapidly growing market.
Job Description: You will be a key member of our Microbiology team and hold responsibility for enhancing our sterility assurance programme, ensuring it meets all aspects of international aseptic processing requirements. The initial priority for this role will be to establish the microbiology function at eXmoor. Initially to build the environmental monitoring capabilities and then to bring further microbiology testing such as sterility and endotoxin in-house and establish the microbiology team. Main areas of responsibility / key duties: Microbiology Testing Perform routine and non-routine microbiological testing, including: Bioburden testing Sterility testing Endotoxin testing (LAL) Microbial identification Conduct growth promotion testing of media
Environmental Monitoring You will be responsible for the environmental monitoring of cleanrooms (Grades A–C), including:
- Air sampling (active/passive)
- Surface monitoring -Personnel monitoring You will trend and analyse environmental monitoring data to identify deviations, risks and suggest appropriate corrective and preventive actions where appropriate. You will author quarterly Environmental Monitoring reports.
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Laboratory Operations You will lead the establishment of microbiology laboratories within the facility. You will manage the testing of samples and provision of the results. You will maintain aseptic techniques and good laboratory practices (GLP & GMP). You will prepare culture media and reagents as required. You will ensure equipment calibration, maintenance, and qualification status. You will be responsible for the activities at external microbiology laboratories.
Quality & Compliance You will ensure compliance with GMP, pharmacopoeial standards (e.g., EP, USP), and regulatory guidelines (MHRA, FDA). You will conduct and support investigations (deviations, OOS, OOT) and identify and contribute to root cause analysis and CAPAs. You will assist in audits and inspections (internal and external). You will own the contamination control strategy for the eXmoor site You will support the review and development of procedures for all microbial assurance activities such as Aseptic Processing Simulation, material handling and transfer, operator training, cleaning and aseptic practices, filter integrity testing, cleanroom behaviours, environmental monitoring and microbial control. You will provide microbiological and aseptic training program for clean room and other appropriate staff. You will be responsible for the management and monitoring of the cleaning and disinfection programme You will apply quality risk management principles to evaluate and control all aspects of the sterility assurance of products and processes.
Documentation & Data Integrity You will accurately complete laboratory documentation, ensuring ALCOA+ data integrity principles. You will review and verify microbiological records from external suppliers You will generate and review microbiological reports You will trend and analyse microbiological results and escalate adverse trends
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Continuous Improvement You will identify opportunities to improve laboratory processes and efficiency. You will support validation activities (e.g., method validation, disinfectant efficacy studies). Person Specification: Essential Qualifications & Experience: Degree in Microbiology, Biology, or related life science discipline or equivalent experience Excellent understanding and proven background of working effectively in a GMP QC Microbiology department (5+ years preferably). Strong knowledge of cGMP microbiology and sterility testing, media fills/ simulations, environmental monitoring, cleanroom qualification/management and contamination control strategies. Familiarity with cleanroom classification and monitoring. Experience with rapid microbiological methods. Equipment and method qualification relating to microbiology methods. Ability to work within graded cleanroom environments, adhering to local personnel gowning & cleanroom behaviour SOP's Prior experience of establishing a microbiology lab Exceptional organisational and planning skills with the ability to plan whilst delivering results to deadline.
Desirable Qualifications & Experience: Experience in a CMO/ CDMO environment. Experience in cell culture and cell and gene therapy. Competences Required: Organisation, planning and time management Oral and written communication skills Strong problem-solving and investigation capability Leadership and teamworking Innovation, inquisitiveness, and willingness to learn Attention to detail and getting things finished Problem solving Building constructive relationships and earning respect Proficiency in Office365 (including Word, Excel, PowerPoint).
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