QC Analytical Scientist

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 Title:

QC Analytical Scientist Reports to Manager/Senior Manager, QC Analytical Department:
Quality Control

Hours:

Shift based:
Sunday – Wednesday/Wednesday to Saturday (0600AM to 1545PM /12:15PM to 22:00PM - 2 weekly shift rotation)

Location:

Stevenage

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 team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and autoimmune diseases 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 a comprehensive benefits package.

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.

Quality Control Analytical manages and executes all routine testing using validated analytical methods and following prescribed testing plans. Test results allow to monitor and drive the manufacturing processes, release the product or material, determine shelf life of the product or material and assess potency, quantity, identity and safety against defined specifications. The role of QC Scientist (Analytical) is predominately lab based and involves performing in process and release testing, leading minor quality events, identifying and implementing continuous improvement initiatives, executing validation/tech transfer protocols.

• Execution of analytical tests - in process drug product samples (ddPCR based methods, Sterility Testing, Endotoxin, Flow Cytometry)
• Execution of analytical tests - release drug product samples (ddPCR based methods, Sterility Testing, Endotoxin, Flow Cytometry)
• Laboratory housekeeping - maintenance of laboratory in inspection ready state
• Reagent preparation (e.g., preparation of media, aliquots, controls)
• Management of QC materials (e.g., media preparation, aliquoting, stock management)
• Operation and maintenance of analytical instruments in accordance to governing SOPs
• Participation in execution of qualification scripts (IOPQ)
• Conducting root cause analysis using appropriate tools
• Initiation and investigation of deviation, laboratory investigation, change control or CAPA as required
• Performing impact assessment for minor deviations and minor change controls
• Leading internal QC investigations forming part of deviation, laboratory investigation
• Defining and implementing effective CAPA within QC
• Ownership of minor internal QC change controls
• Data entry / collation for tracking and trending purposes
• Review of QC records
• Preparation of calculating spreadsheets following guidelines
• Archiving of GMP records
• Completion of GMP documentation in accordance with ALCOA/data integrity requirements
• Designing GMP documentation (e.g., logbooks, forms)
• Managing GMP documentation (logbooks, worksheets,…