QC Microbiology Manager
My client is an emerging cancer immunotherapy company developing cell-based treatments for cancer and severe viral infections. The company has a clear vision to make CAR-T mainstream therapy for eradicating cancer. They are developing safer, cheaper, consistent, and durable CAR-T drugs for haematological and solid tumours.
They are now looking for a QC Microbiology Manager to join their team! They’re growing quickly, and this is an opportunity to become an integral member of their management team.
Previous microbiology experience in GMP sterile manufacturing is an essential requirement for this position. Previous management experience would be beneficial.
***What will you do? ***
• Accountability for all QC Microbiology procedures within the multipurpose cleanroom facility.
• Management of Quality Control Microbiology technical staff.
• Review of the microbial control strategy and continuous process improvement.
• Ensuring effective environmental monitoring is conducted for viable and non-viable particles and subsequent reporting of trending data to senior management.
• Investigation of microbiological excursions within the manufacturing facility and reporting of trending analyses. Advising on corrective and preventative actions to improve sterility assurance.
• Developing and validating microbiological assay methods within company timelines.
• Responsibility for the preparation of Quality Control documentation.
• Management and assurance that the quality control management systems, processes and procedures are implemented across the manufacturing facility to ensure that product released is fit for use and is compliant with appropriate regulatory guidelines and commitments.
• Review of data generated from analysis of intermediate and final products in full compliance with the controlled methods and procedures and to GMP requirements.
• Preparation and maintenance of documentation to appropriate quality standards, including, but not limited to, laboratory notebooks, standard operating procedures, protocols and reports, TSE evaluations, COSHH/BIOCOSHH assessments and Risk Assessments.
• Directing laboratory management activities including, but not limited to, equipment planning/procurement, ordering of reagents and consumables, maintaining calibration and servicing records, ensuring equipment compliance and ensuring a clean, organised and smooth-running working environment.
***What do you need? ***
• Degree level education in a sciences discipline.
• Expert knowledge of environmental monitoring of a sterile manufacturing facility.
• 5 years + Microbiological working experience.
• GMP experience within an industry setting.
• Previous management experience in a similar role
• Flexibility and enthusiasm.
Coupled with a competitive salary (reviewed annually), they offer a comprehensive range of benefits and an excellent working environment.
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