Senior Operator, Production in Stevenage

**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.**Job Description:**Job Title: Senior Operator, ProductionReports to: Manager, ProductionDepartment: Product DeliveryHours: 35 hours pw (on bi-weekly shift rotation)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**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 always act in compliance with GMP & to proactively raise any issues* To always act in a safe manner (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* To routinely execute production processes & operate associated process equipment in accordance with GMP & GDP to produce high quality cell-based products, inc.;* Timely & accurate document completion & management* Isolator Hydrogen Peroxide Vapour Gassing* Clean/sterile room maintenance* Clean Room Environmental Monitoring (EM)* Raw Material Transfers* Particulate cleaning & disinfection* Material receipt & drug product shipment* Data entry* 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* **Make (~65%) -** Additional core technical competencies; + Cell processor set up for cell culture activities + Cell culture sampling, counting, washing, activation, feeding & harvesting + Cell culture Magnetic Enrichment & Depletion (MACS) + Drug Product Visual inspection + Process adjustments + Labelling + Reconciliation + To execute non-standard &/or first-time product manufacture under supervision of Product Development / MSAT staff + Aseptic manipulations in Grade A & satisfy associated BROTH qualification (OAQ) + EMS knowledge & management + To execute timely batch review* **Improve (35%)** + 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 + Authoring of SOPs & SWI* To **Lead** + Operational deviations + Process risk assessments, + Authoring of SOPs & SWI + Own & drive change controls + To recognise sources of variability by applying process knowledge & using problem solving tools* **Team** + Accountable for ownership of own development & training + Actively support junior staff member training & development + **Mentor** more junior staff members* **Demonstrated skills and competencies** **E – Essential** **P – Preferred** **Experience*** **~6 years** GMP manufacturing cleanroom experience (E)* 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*** Demonstrate detailed understanding of GxP / sterile / ATMP production (E)* Demonstrate proficiency in environmental, health & safety requirements (E)* Demonstrate working knowledge of QMS (E)* Demonstrate problem solving / process improvement capability (E)* Confident user of MS Office applications inc., Teams, PowerPoint, Excel & Word (P)* Familiarity with problem solving methodologies and/or lean six sigma (P)* Ability to retain the necessary skills & knowledge to confidently work across multiple products / clean room environments (E)* 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**Autolus Core Competencies****Focus on Results:** Works to meet business goals set by management and leaders**Builds Trust and Relationships:** Ensures trust with internal and external partners by delivering on commitments**Resilience:** Has the capacity to recover quickly from difficulties; toughness**Communicates and Collaborates:** Builds partnerships and works collaboratively with others to meet objectivesAutolus’ 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.### Get In TouchIntroduce yourself to our recruiters and we\'ll get in touch if there\'s a role that seems like a good match. #J-18808-Ljbffr