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Microbiologist

3 months ago

Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time

Role Summary

As a 'Microbiologist' you will provide the essential support to the Microbiology team that allows the release of manufactured product to the critically ill patient.

Your role will include microbial enumeration, microscopy & identification, Sterility testing, Bioburden testing, Endotoxin testing, Mycoplasma testing, and defining LEAN processes that allows the team to operate at optimal efficiency.

In this role you will be key participant in the delivery of Microbiological analysis and will develop your practical knowledge to a subject matter expert level.



Key Responsibilities

  • Responsible for supporting the critical operations by ensuring the laboratory and general equipment is maintained to GMP standard, including stock, waste, & sample management, cleaning, calibrations & servicing, and external shipments.
  • Responsible for performing routine testing, including but not limited to, sterility, endotoxin, bioburden, mycoplasma, growth promotion & fertility testing, microbial enumeration, microscopy & microbial identification, and electronic system maintenance (data entry).
  • Responsible for equipment, method, and process qualification, validation, and/or verification to comply with GMP standards.
  • Responsible for leading and supporting quality-related activities such as investigations, deviations, Job Title
Microbiologist Reports to Manager, Microbiology Department Quality Control Hours 35 pw Location Stevenage
CAPAs, and Change Controls.

  • Responsible for leading and supporting GMP documentation creation or revision to ensure assigned projects remain in regulatory compliance, from authoring through to archiving documentation.
  • Responsible for identifying and implementing LEAN processes and principles within the Microbiology function.
  • Responsible for leading and supporting the training of all levels within Microbiology relevant to your role, as well as cross-departmental.
  • Any other duties as required following consultation with the post holder.
  • The post-holder will be responsible for adhering to all health and safety guidance, provided by the Company.