Reporting to the Head of Analytical Science and Technology at Seqirus Liverpool the role is accountable for Quality Control method

validation lifecycle management and method standardisation/robustness. The validation specialist is an SME in testing

methodology, able to troubleshoot technical issues, develop current and existing methods and be current with the latest analytical

testing technologies. The role requires the execution of intra site method transfers and SME input into regulatory filings/audits

alongside validation lifecycle management.

Routine testing support for technical development / MS+T pilot plant manufacturing processes required in support of critical

manufacturing process parameter activities and new strain introduction. (as required)

• • Instrument Maintenance and Calibration
• • Reporting of Results.
• • Reagent and Standard Qualification
• • HSE risk assessment completion, review and adherence
• • Archiving of laboratory documentation,
• • Ordering of reagents and consumables
• • Maintenance of AS+T sample and reagent stores
• • Ensuring a clean and safe workplace for all associates •
• Participation in quality risk assessments

• Experience working in pharmaceuticals, particularly biologics
• Experience of assay development and assay validation
• Experience in elements of assay lifecycle management from proof of concept to registration.
• Experience of Quality Control testing techniques and industry practices.
• Proven time management skills for planning and schedule of work.
• Proven Communication skills both written and verbal.
• Knowledge of continuous improvement techniques and root cause analysis techniques.
• Bachelor's degree in a relevant scientific discipline (Chemistry, Biochemistry, Microbiology preferred)
• Desirable to have experience of process or product characterization using a variety of orthogonal methods.