Senior Microbiologist

** Work with us
** Our team are passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and Autoimmune disease to deliver life-changing treatments to patients.

Whilst working at Autolus you will enjoy a flexible, diverse and dynamic working environment which actively promotes creativity, leadership and teamwork – together we are ONE Autolus.
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* Job Description:

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* Job Title:

Senior Microbiologist I

Reports to:

Manager, Microbiology Department:
Quality Control

Hours:

Shift-based, Wednesday - Saturday (0800AM - 1745PM)

Location:

Stevenage
** About Autolus
** Autolus is a biopharmaceutical company, advancing innovative therapies at both clinical and commercial stages of development, focused on next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled, and highly active T cell therapies designed to better recognize cancer cells, break down their defence mechanisms, and eliminate these cells.

Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies, solid tumours, and autoimmune diseases.
** Why Autolus
** Our team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy to deliver life-changing treatments to patients. Whilst working at Autolus you will enjoy a flexible, diverse, and dynamic working environment which actively promotes creativity, leadership and teamwork. In addition to this Autolus is proud to offer a competitive salary, performance related bonus as well as private medical insurance, life assurance, pension and access to an employee share scheme.

Autolus promotes flexible working.
** Our Promise
** Autolus is developing complex, breakthrough therapies for a globally diverse market and equally recognises that diversity amongst our people is critical to our mission. As we draw on our differences, what we’ve experienced, and how we work, we celebrate diversity and are committed to creating an inclusive environment for all employees
** Role Summary
** As a ‘Senior 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 equipment and method validations, continuous process developments, and supervising the team with day-to-day activities ensuring GMP and regulatory compliance are definitively maintained. You will be supporting the team, as required, in all areas of the department, including but not limited to, Sterility testing, Bioburden testing, Endotoxin testing, Mycoplasma testing, microbial enumeration, microscopy & identification, 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 into a multi-subject matter expert.
** Key Responsibilities
*** Responsible for supporting the critical operations by ensuring the laboratory and general equipment is maintained to GMP standard.
* Responsible for defining and executing microbiology-specific equipment qualifications, method validations, and continuous process development to ensure constant GMP compliance with regards to CMC, Pharmacopeial monographs, and regulatory guidance.
* 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 leading and supporting quality-related activities such as investigations, deviations, 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 leading batch certification for Microbiology-related testing; ensuring all associated actions are complete.
* Responsible for identifying and…