We are currently seeking to recruit a Senior QC Microbiologist to become a key member of the quality team within a leading biopharma multinational.
The successful candidate would be responsible for one or more of the following activities in QC including microbiological testing, method transfers, sample and data management and equipment maintenance.
• Endotoxin testing of water, in-process and drug product release samples
• Bioburden testing of water & in-process drug product samples
• Sterility testing
• Water sampling
• Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave.
• Writing technical reports
• Perform analytical testing as a main priority with efficiency and accuracy
• Plan and perform multiple routine/ non-routine methods and procedures with a large variety of assays.
• Initiate and/or implement changes in controlled documents.
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
• Write protocols and perform assay validation.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
• Bachelors degree in a science discipline
• Biopharmaceutical QC experience in a microbiology lab
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
• Experience working in endotoxin, bioburden or sterility testing
• Proficient in GMP systems such as LIMS Labware & LMES
• Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.