Scientific Manager

Career Opportunities : Scientific Manager (18981)

Requisition ID 18981 - Posted - BIOCON SDN BHD - PROCESS R&D - DOWNSTREAM PROCESS - Malaysia

Key Responsibilities

• Guide the team for statistical evaluation of comparability assessment and DS stability using different techniques such as tolerance interval, Mixed model ANOVA and confidence interval approach whenever required.
• Guide the team for performing data trending and analysis for root cause investigation and CAPA identification for the deviations at manufacturing scale.
• Support manufacturing investigations and process improvements using data analysis and regression technique.
• Guide the team to perform process monitoring of Manufacturing In-process data using Statistical process control charts (xbar, LJ and range charts) to visualize the performance of process over time and detect the onset of abnormal occurrences.
• To involve in technical discussions (Internal & CFT) and support the process related troubleshooting activities (at pilot and MFG scale) as and which required.
• Identify the opportunities for establishing the platform for online manufacturing data retrieval, data modelling and predictive simulations.
• To involve in comparability exercise, CPV, OOT reports and technical assessment reports.
• Support to process and analytical development including;
• Process comparability evaluation using Student T-test, Equivalence Test, Tolerance Interval, Confidence Interval etc.
• DOE experimental planning and analysis.
• Support manufacturing excellence initiatives using data analysis as required.
• Develop Predictive models between input and output of specific process by Multiple linear regression (MLR) which involves techniques like PCA and PLS using SIMCA and JMP.
• Responsible for the usage of SIMCA software and for Multivariate data analysis and guide the team to perform analysis using SIMCA.
• Preparation and review of reports such as CPV report, technical report, OOT report.

Additional Responsibilities (If Any)

Educational Qualifications

Required Education Qualification : Bsc

Required Experience : 1 - 5 years

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