Investigator, QC Microbiology

Investigator, QC Microbiology page is loaded## Investigator, QC Microbiologylocations:
UK - Stevenagetime type:
Full time posted on:
Posted Todayjob requisition :
JR100056
** 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:

Investigator, QC Microbiology

Reports to:

Senior Manager/Associate Director, Sterility Assurance Department:
Quality Control

Hours:

Full Time (hybrid)

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
** The Investigator, QC Microbiology will provide quality systems support for microbiology compliance within a GMP manufacturing environment. This non-lab facing role is primarily focused on leading and managing microbiology-related investigations, performing product and sterility impact assessments, supporting change controls, and acting as a conduit between QC, QA, and Production. The Investigator ensures robust microbial control and sterility assurance standards are consistently applied, contributing to safe and compliant production of cell and gene therapy products.
** Key Responsibilities
*** Lead and author microbiology-related investigations, including EM excursions, OOS, OOT, and deviations, ensuring root cause analysis and effective CAPAs
* Perform product quality and sterility impact assessments, liaising with QPs, QA, and Production
* Support environmental monitoring trending, microbial contamination assessments, and microbiology analytical data trending including sterility, mycoplasma and endotoxin
* Manage and contribute to change controls affecting sterility assurance of the facility and process, QC Microbiology systems, methods, and quality processes
* Ensure compliance with regulatory expectations, including EU Annex 1, USP, EP, and internal standards
* Partner closely with Manufacturing, Production Support, QA, and Validation to ensure timely resolution of issues
* Participate in continuous improvement initiatives to enhance microbiological controls and quality system performance
* Support internal and external audits, inspections, and regulatory submissions with subject matter expertise in microbiology and sterility assurance
* Provide technical guidance and support to junior colleagues and cross-functional teams on microbiology and sterility assurance
* Participate in risk assessments, deviation trend analysis,…