Our client is a well‑established and successful manufacturer looking for a Microbiology Manager to join their team. The role will ensure that microbiological quality control systems and activities, associated training, and environmental monitoring within the company meet cGMP regulation and guidelines.
In this role you will provide effective leadership within the microbiological laboratory, ensuring proper functioning of the team and an efficient, smooth flow of analyses.
Salary: £50,000 + benefits (including 8% pension)
Hours of work: 8:00 am – 4:00 pm, Monday to Friday (every other Friday off)
Requirements
* Minimum of 3 years of relevant experience in a Pharmaceutical GMP quality control laboratory
* Experience managing a team, including coaching and mentoring
* BSc Hons in Microbiology or equivalent scientific field, or relevant experience
* Strong knowledge of USP, EU, and ISO regulations
* Knowledge of microbiological testing such as LAL, membrane filtration, bioburden, environmental monitoring, dispersion, microscope use, Gram staining, and sample incubation
* Computer literacy, including Word and Excel
* Excellent concise technical writing skills with attention to detail and ability to format for clarity
* Knowledge of environmental, health and safety, and regulatory standards
* Prior experience writing protocols, data review, authoring SOPS, change controls, out‑of‑spec investigations, and report writing
* Strong analytical and problem‑solving skills
Team Responsibilities
* Sample facilities and utilities using active air, settle plates, contact plates, swabs and rinses
* Execute microbiological tests including water testing (LAL & membrane filtration), bioburden testing, environmental monitoring, and dispersion testing using a microscope
* Perform analysis for process, product, cleaning and equipment validation studies
* Conduct analysis for stability studies and method transfer
* Coordinate, prepare and dispatch samples to external laboratories for analysis
* Manage third‑party laboratory results
* Perform regular maintenance and minor repairs, keep equipment clean and calibrated, maintain materials and spaces
* Manage inventory and orders of microbiological stock, consumer goods and equipment parts
Key Responsibilities
* Lead, coach, train and motivate Microbiologists, conduct performance reviews, development interviews, etc.
* Stay abreast of developments in the field through training, literature, and documentation
* Provide technical expertise to update methodologies and best practices
* Ensure microbiological best practices are adhered to for all site projects, particularly those involving new equipment, technology, analytical methods, processes or materials
* Stimulate safe working and continuous improvement of the quality culture
* Support the continuous improvement program throughout the company
* Collaborate cross‑functionally to manage departmental processes, ensuring common goals are met and plans are implemented
* Support the generation of resource plans
* Participate in operational and internal quality meetings
* Perform out‑of‑spec investigations, environmental excursion investigations and deviations per company procedures
* Develop and validate testing methods for routine analysis of incoming raw materials and finished products
* Assist in writing validation protocols, project reports, updating laboratory documentation, SOPs, and test methods
* Provide strategic influence to ensure good practices are implemented and maintained in manufacturing areas
* Provide microbiological expertise during the planning and introduction of new procedures, products and process improvements
* Perform quality assessments of microbiological performance related to utilities, HVAC, bioburden and environmental monitoring in support of batch release by the QP
* Lead investigations on microbiology‑related excursions and support production, quality control and quality assurance groups during investigations
* Participate in special projects such as Disinfectant Efficacy studies
* Approve monthly microbiology and environmental monitoring trend reports of production areas and utilities
* Collaborate with QC microbiologists on trending programmes and corrective actions
* Devise and provide technical training and underpinning knowledge to manufacturing and analytical departments to improve microbiological knowledge and understanding
* Represent the company at regulatory inspections (including FDA and MHRA) and respond to questions
* Prepare and review regulatory documentation (CMC) and respond to information requests from agencies
* Perform all other tasks reasonably requested and approved by management
* Ensure personal and others’ health and safety, compliance with company safety and quality systems and legislation, and report incidents or suggestions to the manager
* Ensure all waste is safely removed and in line with business processes
Relevant Previous Titles
QC Microbiology Manager, Microbiological Manager, Microbiology Team Leader, Microbiology Supervisor, Lab Manager, Lab Team Leader, Lab Supervisor, Laboratory Manager, Pharmaceutical Quality Control Manager, Pharmaceutical Quality Assurance Manager, Microbiology Laboratory Manager, Operational Manager of Microbiology, Microbiology Shift Manager, Microbiology Technical Manager, Lead QC & Lab Operations, Scientific Manager, Microbiology Technical Specialist.
#J-18808-Ljbffr