Microbiology Manager in Stevenage

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.

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.

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

Quality Control Microbiology manages and executes routine safety testing using validated analytical methods and following prescribed testing plans. Function is responsible for execution and management of environmental monitoring programs in Autolus manufacturing facilities. In addition, microbiology function also manages the process of operator aseptic qualification and aseptic process simulation. QC Microbiology plays an important role in Autolus’ Sterility Assurance and Contamination Control Strategy programme. QC Manager (Microbiology) leads a team of Microbiologists covering 7 days operation. Job holder is responsible for efficient provision of QC Microbiology services to production and other internal and external customers by overseeing testing schedules, schedule adherence to comply with internal and external deadlines, and establishing effective communication between all stakeholders. The QC Manager monitors, maintains and drives continuous improvement in compliance and an analytical programme within the team and across the department, and drives streamlining of processes with a focus of removing waste. The QC Microbiology Manager will also interact with multiple functions within the business to guarantee smooth and concise information exchange.

Key Responsibilities

• Ensuring adherence to Health and Safety (HSE) policies and procedures within the team
• Managing a team of Pharmaceutical Microbiologists (performance assessments, improvement, and development plans)
• Establishing SMART objectives for team members in alignment with overall QC and business objectives, and continuous progress monitoring
• Managing QC schedule (creation, adherence) to ensure timely delivery of results to production and allow timely batch disposition/certifications
• Managing workload and capacity for the team and assigning adequate priorities (capacity plan)
• Maintaining the QC laboratory in inspection ready state
• Overviewing, assigning and ensuring adequate training level within the team
• Collation and presentation of team metrics and data
• Driving and contributing to ongoing optimisation of our existing processes and analytical methods incl. automatization
• Managing the batch certification process (e.g., data review, approval, quality events)
• Developing and implementing continuous improvement projects using LEAN
• Overseeing Deviations (QE’s), Change requests, Laboratory Investigations, SOPs, together with leading systematic problem solving
• Looking after the wellbeing of the team
• Coordination of shift activities with Production counterparts (e.g. Environmental Monitoring in Production Cleanroom facility)
• Cooperation with other QC Managers to ensure testing and compliance continuity
• Execution of self-inspections within QC and implementation of CAPA
• Cross functional teamworking e.g. with Production, Validation and Engineering to ensure GMP status of analytical instruments and QC facilities
• Working closely with QA to efficiently manage all aspects of quality and compliance related to Quality Control
• On call for EMS system in QC laboratory
• Any other duties as required following consultation with the post holder

Experience of Pharmaceutical Regulatory Agency GMP inspections (e.g., MHRA, FDA, EMA) is preferred.

Demonstrated skills and competencies

E – Essential

P – Preferred

Experience

• Min 3 years’ experience as a Microbiology Manager in GxP regulated environment, preferably from within QC function within ATMPs, Biologicals or Biopharmaceuticals managing testing teams.
• Min 5 years' experience in Microbiology Laboratory facility

Qualifications

• BSc/MSc degree in life sciences (P) or significant relevant industry experience

Skills/Specialist knowledge

• Open to working shifts (E)
• Previously experience preferred working in a cleanroom, and/or aseptic environment (P)
• Conflict resolution skills (E)
• Experience and demonstrated knowledge of aseptic techniques and practices
• Experience in troubleshooting and relevant tools (5xWhy, Root Cause Analysis)
• Extensive knowledge of LEAN, GMP & Microbiology
• Experience within EM, ID and BI analysis including Mycoplasma and Endotoxin testing (P)
• Familiarity with Annex 1 and Contamination Control Strategies for (E)
• Familiarity with analytical procedure lifecycle (validation, tech transfer, verification) (P)
• Familiarity with regulations governing Stability testing and shelf-life management (P)
• Familiarity with analytical equipment qualification lifecycle (P)
• Experience with QMS quality events and Out of Specification (OOS) in Environmental Monitoring (application, conduct, timely closure) (E)
• Demonstrated experience of representing a function at high level cross-functional meetings with minimal support required (E)
• Highly Proficient in MS Word, Excel, Power Point, DOE and any other relevant applications (E)
• Demonstrated experience in mentorship, supervision, and management of experienced members of team (E)