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Data Statistician, Manufacturing Sciences & Technology (MS&T)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Start date
Nov 5, 2022
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Job Details

Job Description

The Opportunity

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.

The Role

  • Use your experience with statistics in biopharmaceutical processes to provide technical leadership in the performance of complex statistical analysis required for:

  • Regression analyses

  • OOS / OOT / OOL / Deviation Investigations

  • Process comparability design and analysis

  • Process Improvement

  • Capability Assessment

  • 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.

About Us

Our Benefits

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.

About 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.

Do work that matters at Seqirus!

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Find Us
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States
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