QC Analytical Scientist

Autolus-Ltd-; Stevenage; On-site; GBP 42,000 - 64,000; Full time

Job summary

Autolus Ltd in Stevenage is seeking a QC Analytical Scientist to join the Quality Control team. This lab-based role involves executing in-process and release testing to support manufacturing, drive process improvements, and ensure product quality in a GMP environment.

You will perform ddPCR based methods, sterility and endotoxin testing, flow cytometry, and maintain instrument readiness. The role requires 5+ years in a QC lab and a life sciences degree, with shift flexibility and meticulous

Qualifications

• Strong attention to detail and accuracy in GMP-compliant documentation
• Good written and verbal communication in English
• Ability to work in a fast-paced, team-oriented environment
• Willingness to work shifts and maintain flexibility
• Experience in cleanroom environments would be advantageous

Responsibilities

• Execute analytical tests for in-process and release samples using validated methods
• Perform ddPCR based methods, Sterility Testing, Endotoxin, Flow Cytometry
• Maintain laboratory housekeeping and instrumentation in inspection-ready state
• Lead investigations related to deviations, CAPA and change controls as required
• Prepare GMP-compliant documentation and support tech transfer/validation activities

Job description

Work with usOur 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: QC Analytical ScientistReports to Manager/Senior Manager, QC AnalyticalDepartment: Quality ControlHours: Shift based: Sunday – Wednesday/Wednesday to Saturday(0600AM to 1545PM /12:15PM to 22:00PM - 2 weekly shift rotation)Location: StevenageAbout AutolusAutolus 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 AutolusOur 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 PromiseAutolus 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 SummaryQuality 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 ResponsibilitiesExecution 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 stateReagent 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 SOPsParticipation in execution of qualification scripts (IOPQ)Conducting root cause analysis using appropriate toolsInitiation and investigation of deviation, laboratory investigation, change control or CAPA as requiredPerforming impact assessment for minor deviations and minor change controlsLeading internal QC investigations forming part of deviation, laboratory investigationDefining and implementing effective CAPA within QCOwnership of minor internal QC change controlsData entry / collation for tracking and trending purposesReview of QC recordsPreparation of calculating spreadsheets following guidelinesArchiving of GMP recordsCompletion of GMP documentation in accordance with ALCOA/data integrity requirementsDesigning GMP documentation (e.g., logbooks, forms)Managing GMP documentation (logbooks, worksheets, documentation trackers)Timely completion of own quality eventsDesigning worksheetsPreparation of high quality SOPs using approved templates (general QC procedures)Preparation of certificate of analysisParticipation in tech transfer, validation / verification of analytical methodsAny other duties as required following consultation with the post holderWork in adherence to local Health and Safety policies and SOPsDemonstrated skills and competenciesE – EssentialP – PreferredExperienceMinimum 5 years’ experience within a QC laboratory, without BSc/MSc degree in life sciencesMinimum 2 years’ experience within a QC laboratory, with BSc/MSc degree in life sciencesNo minimum industry experience, with a PhD in life sciences or relevant subjectQualificationsBSc/MSc degree in life sciences or significant relevant industry experienceSkills/Specialist knowledgeSoft 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 CompetenciesFocus on Results: Works to meet business goals set by management and leadersBuilds Trust and Relationships: Ensures trust with internal and external partners by delivering on commitmentsResilience: Has the capacity to recover quickly from difficulties; toughnessCommunicates and Collaborates: Builds partnerships and works collaboratively with others to meet objectivesAutolus 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 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’ 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.