Job Description
This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the + business community. Please do not contact the recruiter directly.
Key Responsibilities
* Execution of analytical tests on in-process drug product samples
* Execution of analytical tests for drug product release samples (all assays)
* Execution of analytical tests on drug product stability samples
* Execution of analytical tests for vector testing
* Laboratory housekeeping to maintain inspection-ready state
* Reagent preparation (e.g., media, aliquots, controls)
* Management of QC materials (media preparation, aliquoting, stock management)
* Operation and maintenance of analytical instruments following SOPs
* Participation in executing qualification scripts (IOPQ)
* Preparation of User Requirement Specifications for new instruments
* Conducting root cause analysis using appropriate tools
* Initiating deviations, laboratory investigations, change controls, or CAPAs as needed
* Performing impact assessments for major deviations and change controls
* Leading internal QC investigations related to deviations and laboratory issues
* Defining and implementing effective CAPA within QC and other functions
* Owning major internal QC change controls
* Acting as SME in change control processes
* Performing risk assessments for QC procedures and processes
* Data entry and collation for tracking and trending
* Review and approval of QC records
* Preparation of spreadsheets following guidelines
* Designing data trending and tracking approaches
* Archiving GMP records
* Completing GMP documentation per ALCOA/data integrity standards
* Designing GMP documentation (logbooks, forms)
* Managing GMP documentation (logbooks, worksheets, trackers)
* Timely completion of own quality events
* Designing worksheets
* Preparing high-quality SOPs using templates (general QC procedures and methods)
* Preparation and review of certificates of analysis
* Review and approval of SOPs and spreadsheets
* Acting as shift supervisor when required
* Managing batch certification activities
* Implementing QC processes and systems
* Approval of certificates of analysis
* Executing tech transfer, validation, and verification of analytical methods
* Preparing protocols for tech transfer, validation, and verification
* Participating in the preparation of related reports
* Performing other duties as required in consultation with the post holder
* Adhering to local Health and Safety policies and SOPs
Demonstrated Skills and Competencies
E – Essential
Experience:
* 2-5 years’ industrial experience in roles responsible for quality assurance in pharmaceutical or similar systems
* Experience with MHRA (E) and HTA (P) inspections, either as host or involved contractor
Qualifications:
* BSc in pharmaceutical sciences, immunology, or equivalent (E)
* MSc in pharmaceutical sciences, immunology, or equivalent (P)
Skills/Specialist Knowledge:
* GMP & GCP principles
* Manufacturing and testing procedures for advanced therapies
* CAR T-cell technology fundamentals
* Good communication skills and ability to motivate colleagues
* Ability to build cross-departmental relationships
* Teamwork, responsibility, and accountability
* Ability to work independently to high standards with minimal supervision
#J-18808-Ljbffr