Job title: Microbiologist
Reporting to: AS Team Lead
Department: GMP
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 Manufacturing Organisation (CMO). 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 Quality Control 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 medi
Environmental Monitoring
- Responsible for the environmental monitoring of cleanrooms (Grades A–C), including:
- Trend and analyse environmental monitoring data to identify deviations, risks and suggest appropriate corrective and preventive actions where appropriate.
- Author quarterly reports.
Laboratory Operations
- Maintain aseptic techniques and good laboratory practices (GLP & GMP).
- Prepare culture media and reagents as required.
- Ensure equipment calibration, maintenance, and qualification status.
- Responsible for the activities at external microbiology laboratories.
Quality & Compliance
- Ensure compliance with GMP, pharmacopoeial standards (e.g., EP, USP), and regulatory guidelines (MHRA, FDA).
- Support investigations (deviations, OOS, OOT) and contribute to root cause analysis and CAPAs.
- Assist in audits and inspections (internal and external).
- Own the contamination control strategy for the eXmoor site
- 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.
- Provide microbiological and aseptic training program for clean room and other appropriate staff.
- Responsible for the management and monitoring of the cleaning and disinfection programme
Documentation & Data Integrity
- Accurately complete laboratory documentation, ensuring ALCOA+ data integrity principles.
- Review and verify microbiological records and reports.
Continuous Improvement
- Identify opportunities to improve laboratory processes and efficiency.
- Support validation activities (e.g., method validation, disinfectant efficacy studies).
Person Specification:
Essential Qualifications & Experience:
- Degree in Microbiology, Biology, or related life science discipline.
- Experience working in a GMP-regulated pharmaceutical or biotechnology environment.
- Ability to work within graded cleanroom environments, adhering to local personnel gowning & cleanroom behaviour SOP's
- Strong knowledge of cGMP microbiology and sterility testing, media fills/simulations, environmental monitoring, cleanroom qualification/management and contamination control strategies.
- Experience in a CMO/CDMO environment.
- Familiarity with cleanroom classification and monitoring.
- Experience with rapid microbiological methods.
Desirable Qualifications & Experience:
- Prior experience of establishing a microbiology lab
- Equipment and method qualification relating to microbiology methods
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
- Motivated by growing a bio-technology business in the CGT / biopharmaceutical market
- Proficiency in Office365 (including Word, Excel, PowerPoint)