Job Description

Role Summary

This role sits within the Production team at Autolus where there is a shared mission of manufacturing and delivering Autologous products to our patients.


This is a shift base role within a dynamic, bright, enthusiastic and evolving team.

The role will be based on site, within the Autolus Manufacturing site(s) in Stevenage, however, may occasionally involve travel to other sites.

Must meet the requirements of working in a cleanroom/ aseptic environment

Key Responsibilities

To demonstrate initiative & work as a flexible & motivated team member To follow all SOPs/SWI applicable & in which the individual has been trained To act at all times in compliance with GMP & to proactively raise any issues To act in a safe manner at all times (in compliance with the Health & Safety at work act & all other relevant legislation) & to use the appropriate reporting systems to highlight potential hazards To stay up to date with all training requirements as identified in the job holders training plan To participate in continuous improvement (CI), root cause analysis (RCA) & corrective & preventative (CAPA) activities within span of influence

Role specific -

Make

To routinely execute production processes & operate associated process equipment in accordance with GMP & GDP to produce high quality cell-based products, inc.;

o Timely & accurate document completion & management

o Isolator Hydrogen Peroxide Vapour Gassing

o Clean/sterile room maintenance

o Clean Room Environmental Monitoring (EM)

o Raw Material Transfers

o Particulate cleaning & disinfection

o Material receipt & drug product shipment

o Data entry

o Documentation archiving

To ensure that processes, process areas & equipment are never compromised by non-adherence to GMP

Communication

To work effectively with colleagues (inc. different functions) to ensure the smooth flow of materials & information before, during & after production activities

Improve

To use understanding of processes & equipment to support day to day trouble shooting and the identification & progression of improvement activities To update or amend safety & process risk assessments, SOPs, SWI etc to facilitate rapid, controlled cycles of improvement To take on additional roles within the team, as agreed with the individual's manager & in accordance with the Team Plan

Team

Accountable for ownership of own development & training

Demonstrated skills and competencies

E - Essential

P - Preferred

Experience

GMP manufacturing/cleanroom experience or relevant transferable skills is not essential but is preferred (P) Shift work experience is strongly preferred (P) Exposure to high performance/stress conditioned work (P)

Qualifications

Ability to read, write & perform arithmetic at a suitable level (E) - GCSE Mathematics & English or equivalent. Computer Literate (E) Further education diploma/degree (STEM) and/or previous hands-on GMP Manufacturing experience (P)

Skills/Specialist knowledge

Knowledge

Good understanding of GxP / sterile / ATMP production (P)

Skills

Confident user of MS Office applications inc., Teams, PowerPoint, Excel & Word (P) Familiarity with problem solving methodologies and/or lean six sigma (P)

Behaviours

Attention to detail (E) Ability to precisely follow instructions & procedures (E) Ability to make quality-critical decisions (E) Good communication, organisation, teamwork (E) * Curious to learn with a can-do attitude (E)