We’re looking for a motivated and detail-oriented Microbiologist to join our client's busy laboratory team. You’ll help ensure the quality and safety of our products by carrying out routine microbiological testing and supporting day-to-day lab operations. This role offers hands-on experience in a regulated pharmaceutical environment and the chance to make a real impact on product compliance. If you’re passionate about microbiology, we want to hear from you!
Responsibilities:
• Performing bioburden testing on utility samples, drug substance and raw materials within the required hold times.
• Performing bacterial endotoxin testing on utility samples, drug substance and drug product within the required hold times.
• Carrying out the Minute Mouse Virus (MMV) by PCR and quantitative PCR (qPCR) testing of in-process samples.
• Perform compendial verification, method transfer/validation, and routine testing of in-process, drug substance and drug product samples in accordance with applicable procedures and cGMP requirements.
• Performing growth promotion testing of media and organism lots entering the laboratory.
• Performing microbial identifications using MALDI-TOF and MicroSEQ.
• Completing all laboratory documentation in a timely and accurate manner.
• Compliance with Standard Operating Procedures and Registered Specifications.
• Assisting in authoring and reviewing documentation, including SOPs.
• Providing support to other departments to ensure qualification and production schedules are adhered to.
• Reviewing Batch paperwork, and reconciliation of analysis performed in the laboratory.
• Ensuring that any alert/action limit excursions are investigated according to site procedures.
• Ensuring a high standard of housekeeping and safety is maintained in the laboratory.
• Performing any other activities as indicated by the Microbiology Manager.
Qualifications and Experience required:
• The ideal candidate should hold a minimum of a Level 8 degree in Microbiology or related discipline.
• At least 1 years’ experience in a pharmaceutical / healthcare laboratory or related technical function.
• A strong background in Microbiology and aseptic manufacturing is desirable but not essential.
• The successful candidate must demonstrate excellent written and verbal communication skills.
• The ability to work in a team based collaborative environment is essential.