Microbiology Manager

Microbiology Manager

RoslinCT

Edinburgh, United Kingdom

Your new role

We are recruiting for a Microbiology Manager to join our team.

• You will be a key member of our QC management team and hold responsibility for supervising all microbiological techniques and operations regarding the testing of in-process, bulk release and GMP raw materials and management of the QC Microbiology laboratory.
• Supervise all microbiological and environmental monitoring QC testing including environmental, raw material, in-process and final product samples and techniques such as total particulate, Bioburden, Endotoxin and growth promotion testing and microorganism identification.
• Supervise the review of laboratory data and the close out of deviations.
• Schedule microbiological testing alongside other departments.
• Authoring and review of change controls, deviations/investigations, test methods, specifications and SOPs.
• Management of regulatory requirements from MHRA and FDA.
• Supervision of introduction of new methods including Qualification and Validation of new microbiological assays.
• Acting as Subject Matter Expert for microbiology laboratory testing.
• Running and co-ordination of continuous improvement projects.
• Ensure up-to-date training status of all QC Microbiology personnel in line with cGMP and provision of specialist training as necessary.
• Continued coaching and developing of the QC Microbiology team to help staff meet both their career and personal development goals ensuring a cohesive, productive, and highly motivated team.

About you

• Experience working within a cGMP QC Microbiology laboratory.
• Knowledge of GMP/regulatory requirements specifically for Manufacturing and control of aseptically produced products.
• Experience of aseptic operations, product knowledge, and team management.
• Exceptional organisational and planning skills with the ability to plan and deliver results to deadline.
• Able to effectively manage and influence stakeholders’ and customer expectations
• Ability to learn and share knowledge with the management team and the wider team where appropriate.
• Strong oral and written communication skills; able to explain technical or complex concepts in a clear format to both technical and non-technical audiences.
• Excellent interpersonal skills with the ability to build relationships with stakeholders across all levels of seniority.
• Excellent attention to detail with a desire to continually develop and improve our processes.
• A determination to continually develop and improve standards.

Qualifications

• You will hold a BSc (minimum) in Microbiology or related Life Science discipline, or equivalent relevant experience.

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