QC Analytical Scientist

Autolus Ltd; Stevenage; On-site; GBP 42,000 - 63,000; Full time

Benefits offered by this job

Bonus

Medical insurance

Life insurance

Pension

Job summary

Autolus Ltd in Stevenage is seeking a QC Analytical Scientist to join the Quality Control team. The role focuses on in-process and release testing using ddPCR-based methods, sterility testing, endotoxin assays and flow cytometry, supporting manufacturing with compliant documentation.

You will lead data integrity and ALCOA-compliant GMP records, participate in deviation investigations and CAPA, and contribute to continuous improvements in analytical methods and lab workflows in a fast‑paced

Qualifications

• Minimum 5 years’ experience in a QC laboratory (without BSc/MSc).
• Minimum 2 years’ experience in QC with BSc/MSc.
• PhD holders welcome with relevant experience.

Responsibilities

• Perform analytical tests: ddPCR, sterility, endotoxin, flow cytometry.
• Release testing and in-process QC samples.
• Maintain GMP records and data integrity (ALCOA).
• Lead deviations, CAPA and laboratory investigations.

Skills

ddPCR methods

Sterility testing

Endotoxin testing

Flow cytometry

Quality system

Education

BSc/MSc in life sciences

PhD in life sciences (optional)

Tools

LIMS

Job description

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

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 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.

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 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.

Key Responsibilities

• 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, documentation trackers)
• Timely completion of own quality events
• Designing worksheets
• Preparation of high quality SOPs using approved templates (general QC procedures)
• Preparation of certificate of analysis
• Participation in tech transfer, validation / verification of analytical methods
• Any other duties as required following consultation with the post holder
• Work in adherence to local Health and Safety policies and SOPs

Demonstrated skills and competencies

• Experience Minimum 5 years’ experience within a QC laboratory, without BSc/MSc degree in life sciences
• Minimum 2 years’ experience within a QC laboratory, with BSc/MSc degree in life sciences
• No minimum industry experience, with a PhD in life sciences or relevant subject
• Qualifications BSc/MSc degree in life sciences or significant relevant industry experience
• Soft skills (effective written and spoken communication, organisation, teamwork) (E) Ability to precisely follow instructions and procedures (E) Open to working shifts (E) Attention to detail (E) Meet requirements to work in cleanroom environment (E) Good technical writing skills (P) Detailed understanding of the assay or test principles, including pharmacopeial monographs and regulatory guidance. [E] Good knowledge of statistics (calculation of mean, median, standard deviation, %CV), interpretation of statistical analysis results (e.g., t-test, confidence intervals) (E) Reporting of numerical values – significant figures, decimal places, rounding in the context of generating and reporting results (E) Understanding of method performance parameters (e.g., precision, accuracy, linearity, range, LOQ, LOD) (P) Understanding of analytical method validation, verification and tech transfer process (P) Familiarity with relevant regulations governing Quality Control function (e.g., EudraLex, ICH, FDA CFR) (P) Working knowledge of Quality Management System records (e.g., deviation, CAPA, laboratory investigation, change control) (P) Working knowledge of aseptic technique and cell culture methodology (E) Good understanding of principles of analytical instrumentation used in the QC laboratory (E) Experience in LIMS (P)

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 objectives

Autolus is committed to the protection of the personal information that we collect & process and we are fully compliant with General Data Protection Regulations (GDPR).

Autolus is committed to providing an inclusive and fair workplace for all. We are an equal opportunity employer and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic. We also provide reasonable accommodations throughout the recruitment process.

Autolus is committed to the protection of the personal information that we collect & process and we are fully compliant with General Data Protection Regulations (GDPR).

Autolus is committed to providing an inclusive and fair workplace for all. We are an equal opportunity employer and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic. We also provide reasonable accommodations throughout the recruitment process.

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 private medical insurance, life assurance, and pension.

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 private medical insurance, life assurance, and pension.