Data Scientist / Statistician, Manufacturing Sciences & Technology (MS&T)
Company: CSL Plasma
Location: Holly Springs
Posted on: January 27, 2023
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Job Description:
Job DescriptionThe OpportunityIn 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 RoleUse
your experience with statistics in biopharmaceutical processes to
provide technical leadership in the performance of complex
statistical analysis required for:Regression analysesOOS / OOT /
OOL / Deviation InvestigationsProcess comparability design and
analysisProcess ImprovementCapability AssessmentUse a structured
statistical approach to guide the design of projects and
experiments.Lead routine data reviews as part of the Continued
Process Verification programSupport Technical Protocols/Studies to
support process characterization, investigations &
improvements.Lead ongoing statistical development implement and
improve a data-driven approachProvide 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
experienceBachelor'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 UsOur
BenefitsSeqirus 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
SeqirusSeqirus 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 usAs 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
Keywords: CSL Plasma, Cary , Data Scientist / Statistician, Manufacturing Sciences & Technology (MS&T), Other , Holly Springs, North Carolina
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