Analytical Science & Technology AS&T Senior Validation Specialist

Job Description

Responsibilities:Development/Improvement activities:Serve as SME to support Site/Global projects.Proactively identifies scope for improvement or development based on knowledge of short to mid-term business needs.Leads and develops a strategy, plans and manages projects for method development or improvement as identified.Makes data supported decisions on project progression; uses technical expertise to overcome analytical issues.Documents project work as detailed lab book records or under technical protocols and reports as appropriate.Disseminates project findings/status updates at regular meetings/forums within Global AS&T.Represents as an interface between AS&T and key stakeholders (QC, MS&T, Regulatory Affairs).Operations Support:Participates in lab work-load planning with the wider team.Design work plans/projects with a compliance development mindset i.e., GMP adherence.Performs tests in accordance with established methods and properly documents test results.Provides guidance/mentorship/training to other lab staff as required.Evaluates performance of analytical instruments and equipment and recommends new acquisition or replacements initiatives.Authors/Reviewer protocols and reports for suitability studies and investigations to support testing and compliance issues, technical writing proficient.Ensures laboratory instruments are qualified, calibrated and properly maintained and documentation complies with cGMP standards.Assists and maintains standard operating procedures (SOPs), risk assessments and other quality documentation as required.Documents quality issues and performance measures for management review.Qualifications:Bachelor’s degree in a relevant scientific discipline (Chemistry, Biochemistry.)MSc (desirable)PhD (desirable)A recognized expert in Analytical and Biological methods (CE, ELISA, SDS-PAGE)Experience of working in pharmaceuticals, particularly biologics is advantageous. Experience of assay development and validation essential.Assay lifecycle from proof of concept to registration and change management.Desirable to have experience of process or product characterization using a variety orthogonal method.Desirable to have people leader experience and or leading project teams.Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.#LI-MS1Our 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 moreabout 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 Seqirus!Watch our ‘On the Front Line’ video to learn more about CSL Seqirus