QC Analytical Scientist 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.

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.

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:

• E – Essential
• P – Preferred

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

Skills/Specialist knowledge:

• 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 where appropriate. Autolus’ 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.