This is an exciting opportunity for an experienced Microbiologist to join Invicro in West London. Invicro is an expanding company, providing imaging services in support of translational drug discovery and drug development. The London site is involved in the development and manufacture of radiotracers for injection into patients/volunteers as part of clinical programmes.
The Microbiology supervisor principal accountabilities are to perform and provide support and expertise in the sterility testing of radiotracers, and for the environmental monitoring of conditions within the Quality Control (QC) and Production areas.
The role will be responsible for:
- Ensuring day-to-day running of Microbiology laboratory
- Performing in-house sterility testing on radiotracers (including weekend cover) and managing contractor companies for outsourced microbiological testing
- Monitoring and trending of microbiological data
- Documenting microbiological records to ensure compliance with cGMP.
- Regularly reporting of results and summaries of own work to line manager.
- Responsible for microbiological test implementation of new radiotracers: method development, validation and documentation.
- Execution of Media Fills & protocols required as part of sterile process assurance
- Taking the leadership for assembly of sterile vials used in PET (Positron Emission Tomography) product manufacture
- Performing routine QC testing to support clinical and pre-clinical studies when required.
- Investigations of out of specifications/atypical results obtained from microbiological testing
- Keeping procedural documents and policies on Environmental Monitoring relevant and up to date with Regulation guidelines.
- Leading site compliance and remedial activities in microbiologically related areas
- Validation and Qualification of Isolators Gassing Cycles
- Responsible for maintaining microbiology laboratory equipment, and supporting new equipment installation as required
- Monitoring of water systems used in PET product manufacture
- Presenting technical microbiological issues and results to internal and external audits
- Continuous improvement of the sterile process assurance.
- Training new members of staff in microbiology related activities
- Line management responsibility for Laboratory Technician
To be considered for this position you will have:
- A BSc/MSc Degree or equivalent in a relevant field
- A minimum of 5 year-experience of working in microbiology, specifically supporting sterility testing and environmental monitoring activities in pharmaceutical environment
- Good understanding of GMP and ability to front external audits
- Good Microsoft Office skills
- Excellent Communication and Team working skills
- Preferably, experience of working with short-lived radioisotopes (Especially Carbon-11 and Fluorine 18)
Competitive Salary & Benefits
Contributory Pension, Bonus, Private Medical Insurance, Life Assurance & Flexible Benefits options
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Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.