Summary: To provide statistical support and promote the use of statistical thinking across the site. To establish, organise and maintain effective statistics and data evaluation services pertaining to process monitoring and modelling of biological drugs.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Apply data visualization tools and implement dashboard solutions that are customer focused, to translate data into useful information for operations managers and process engineers.
• Analyse data sources and develop strategies and solutions for data acquisition, aggregation and reporting.
• Support the development of automated solutions that address specific analytical objectives and facilitate report generation and distribution of analyses to support the manufacturing performance monitoring process.
• Support the implementation, expansion and continuous improvement of the In-Process Control (IPC) program
• Perform activities in relation to creating and improving process models/hierarchies within the Discoverant software environment from collection of user requirements to validation and deployment of solutions to production.
• Apply advanced numerical and statistical techniques including multivariate analysis (PCA and PLS), curve metrics and golden batch analysis to analyze large datasets of process and raw materials data and generate predictive models to supplement and enhance process understanding.
• Participate in cross functional teams to understand process issues in technical investigations to aid problem solving and identify process improvements.
• Issue knowledge base reports summarising conclusion of data analysis and recommendations for process improvements.
• Present findings at group and interdepartmental meetings.
Education and Experience:
• PhD in Statistics/Mathematics or a related field with 0-2 years experience; may consider another discipline with added relevant experience. Experience in a biopharmaceutical setting is desirable.
• Candidates with an MSc Statistics or related field with 4+ years experience will also be considered. Experience in a biopharmaceutical setting is desirable