Investigator, QC Microbiology in Stevenage

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.

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, and quality metrics reporting
• Ensure timely closure of investigations, CAPAs, and quality actions in line with company procedures
• Monitor and report on KPIs related to microbiology investigations, environmental monitoring, and system compliance

Qualifications

• 5-10 years experience in microbiology or sterility assurance within a GMP environment (E)
• Demonstrated experience managing investigations and producing high-quality reports (E)
• Knowledge of key regulatory standards (Annex 1, USP, EP) and microbial contamination control in aseptic processing (E)
• Experience with environmental monitoring programs and trending data (E)
• Experience with performance of microbiological assays per USP/EP: sterility, endotoxin and mycoplasma (E)
• Experience performing product impact assessments and interfacing with QPs (E)
• Experience in change control review and quality systems support (E)
• Experience with data analysis tools (e.g., Minitab, Excel) (P)
• Previous experience in cell and gene therapy manufacturing (P)

Core Competencies

• Strong cross‑functional collaboration and stakeholder engagement (E)
• Proactive mindset with solutions‑oriented problem‑solving skills (E)
• Strong written and verbal communication skills, able to convey complex microbiology issues clearly (E)
• Ability to prioritise workload, manage multiple investigations, and meet deadlines (E)
• Influencing skills to drive timely closure of investigations and compliance actions (E)

Education

• Degree in Microbiology, Biological Sciences, or related discipline (E)
• Advanced training in GMP, aseptic processing, or sterility assurance (P)

Company Overview

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.

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 recognise 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.

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, Autolus\’ success is driven by equality and inclusion; we believe all voices are of equal value and must be heard. Whilst operating with focus and integrity, we are committed to improving diversity and inclusion within our business and our industry.

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.