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SCIENTIST 1

SCIENTIST 1

BIOCON SDN BHDMalaysia
23 days ago
Job description

Department Details

Role Summary

PROCESS R&D - DATA ANALYTICS (L3-Scientist)

1. Support manufacturing investigations and process improvements using data analysis and

regression technique.

2. Perform process monitoring of Manufacturing In process data using Statistical process

control charts to visualize the performance of process over time and detect the onset of

abnormal occurrences

3. Statistical evaluation of DS stability using confidence interval and mixed mode ANOVA

approach whenever required.

4. To involve in technical discussions (Internal & CFT) and support the process related

troubleshooting activities (at pilot and MFG scale) as and which required.

5. Drafting and review of CPV protocol and CPV report.

6. 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.

7. Support manufacturing excellence initiatives using data analysis as required

8. 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.

9. Manufacturing data collection from the difference equipment�s for process

investigation / improvements

10. To prepare and review the protocols and technical reports as required

11. Learn and use the statistical data analysis software such as Minitab, JMP SAS and SIMCA

12. Work towards the implementation of MVDA and PAT as part of operation excellence

13. Perform data analysis and co-author CPV and OOT reports

Key Responsibilities

PROCESS R&D - DATA ANALYTICS (L3-Scientist)

1. Support manufacturing investigations and process improvements using data analysis and

regression technique.

2. Perform process monitoring of Manufacturing In process data using Statistical process

control charts to visualize the performance of process over time and detect the onset of

abnormal occurrences

3. Statistical evaluation of DS stability using confidence interval and mixed mode ANOVA

approach whenever required.

4. To involve in technical discussions (Internal & CFT) and support the process related

troubleshooting activities (at pilot and MFG scale) as and which required.

5. Drafting and review of CPV protocol and CPV report.

6. 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.

7. Support manufacturing excellence initiatives using data analysis as required

8. 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.

9. Manufacturing data collection from the difference equipment�s for process

investigation / improvements

10. To prepare and review the protocols and technical reports as required

11. Learn and use the statistical data analysis software such as Minitab, JMP SAS and SIMCA

12. Work towards the implementation of MVDA and PAT as part of operation excellence

13. Perform data analysis and co-author CPV and OOT reports

Educational Qualifications

Required Education Qualification :

Required Experience : 1 - 3 years

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Scientist • Malaysia