Role: Senior Microbiologist
Location: Leicestershire
Inizio Engage are recruiting for a Senior Microbiologist on behalf of their client based in Leicestershire. This opportunity will be to schedule, carry out and report approved tests and monitoring procedures used to assess the microbiological quality of non-sterile and sterile pharmaceutical materials
Day to day duties will include:
- Plan, carry out and report validation and testing of non-sterile/sterile products to meet agreed schedule, including in-process and finished products covering unlicensed medicines, investigational medicinal products, and Stryker antibiotic bone cement licensed products:
o Sterility test materials inside a gassed isolator by membrane filtration or direct inoculation
o Biological assays on antibiotics
oEndotoxin by KQCL
- Plan, perform (where appropriate) and report microbiological and physical monitoring of production facilities and equipment.
- Plan, carry out and report testing to support validation of sterile production facilities e.g. oven validation, isolator qualification
- Plan, carry out and report testing of raw materials, arranging external testing when required.
- Plan, carry out and report testing of media fills
- To perform all laboratory activities safely, in accordance with GMP, and to agreed timelines.
- Prepare, select and control the storage of microbiological culture media.
- Co-ordinate the investigation of out of specification results, preparation of resulting reports and liaise with QA.
- Preparation or review of standard operational procedures.
The successful candidate will have:
- Experience of working in a pharmaceutical microbiology laboratory environment
- People management skills
- Knowledge of microbiology techniques