In this role, you will report to the Manager, Direct Analytics & Process Monitoring, and be part of the Manufacturing Sciences & Technology team at the Holly Springs Influenza Vaccine manufacturing facility, supporting Bulk and Fill Finish Operations. The MS&T function provides strategic technical direction to manufacturing organizations (including 3rd parties) to achieve supply targets and maximize capacity. You will have responsibilities including providing analytical expertise related to the collection, assessment, comparison, and interpretation of data sets derived from manufacturing.
Use your experience with statistics in biopharmaceutical processes to provide technical leadership in the performance of complex statistical analysis required for:
OOS / OOT / OOL / Deviation Investigations
Process comparability design and analysis
Use a structured statistical approach to guide the design of projects and experiments.
Lead routine data reviews as part of the Continued Process Verification program
Support Technical Protocols/Studies to support process characterization, investigations & improvements.
Lead ongoing statistical development implement and improve a data-driven approach
Provide input to internal and regulatory audits, serving as SME for statistical methods applied in determining results.
Analyze available data to identify potential means of improving yield/throughput/capacity, COGs, product quality, and process efficiency.
Manage process monitoring tools (Excel (can write advanced macros) / R Scripts / Business Intelligence Dashboards)
Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify causes of product and process failures.
Major contributor to the analytical portion of the Annual Product Reviews.
Author, reviewer, and approver of analytical protocols and reports where statistical input is necessary (example: seasonal blend targets)
Your skills and experience
Bachelor's degree required. Advanced degree in Data Science or Statistical discipline preferred.
Understanding of scientific and statistical principles and the ability to apply your knowledge.
Educate others on statistical principles and methodologies.
Experience of statistical software (SAS / JMP / Minitab / or similar)
Experience and comfort coding in statistical programming languages (such as R).
Experience with Business Intelligence software (Power BI / Tableau / SAP Analytics Cloud / Qlik / or similar)
Direct experience with regulated environments (i.e. cGMP)
Excellent planning, time, and project management skills.
Benefits: Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.
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 Seqirus.
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.
We want Seqirus to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.
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