Analytical Science and Technology Senior Validation Specialist
4 weeks ago
Reporting to the Analytical Science and Technology manager at Seqirus, you will be accountable for Quality Control method validation lifecycle management and method standardisation/robustness. You will be 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. The role will involve GMP execution of development and technical assays in support of both egg and cell characterisation samples. You will be based at our Liverpool site.
If you think you are the right match for the following opportunity, apply after reading the complete description.
Responsibilities
Maintain the compliant status of Quality Control method validation lifecycle.
Trouble shoot technical challenges with Quality Control test methods.
Execution of intra site method transfers and SME input into regulatory filings/audits.
Execution of method standardisation and robustness program.
Development of current and new test methods.
Engaged with the latest testing technologies.
Accountable for Liverpool QC method validation lifecycle, method transfers and improvements.
Qualifications
Recognized expert in analytical chromatographic methods (HPLC, UPLC).
Experience working in pharmaceuticals, particularly biologics (PAGE, CE).
Experience of assay development and validation and in assay lifecycle 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 advanced root cause analysis techniques.
Bachelor’s degree in a relevant scientific discipline (Chemistry, Biochemistry.
Desirable to have experience of process or product characterization using a variety orthogonal methods.
Please note this is a 24 month FTC.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
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Our BenefitsCSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.
About CSL Seqirus CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.We want Seqirus to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL SeqirusWatch our ‘On the Front Line’ video to learn more about CSL Seqirus
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