Job Description

Department DetailsRole Summary1. Responsible to involve in downstream process transfer from Biocon India to Biocon Malaysia for downstream unit operations.
2. Responsible to involve in process transfer from R&D to manufacturing facility.
3. Responsible for good documentation practice and continuous practice & implementation of quality and EHS systems.
4. Fulfil the training needs identified for effective execution of job function.
5. Perform process familiarisation and establishment at Biocon Malaysia for process received from Biocon India.
6. Involve in root cause investigation and CAPA identification for deviations observed at manufacturing scale operations and methodology to avoid potential deviations.
7. Perform experimental studies as part of investigation and troubleshooting to support manufacturing operations.
8. Perform lab and pilot scale validations.
9. Conduct process improvements, process optimization, and evaluation of alternate techniques for the process to reduce overall COGs.
10. Discuss on experimental plans and periodically report the results and conclusions to the team leader/supervisor, to enable continuous flow of information.
11. Responsible for data monitoring of manufacturing scale batches and perform data analysis to evaluate trends.
12. Identify the requirements for process transfer to manufacturing scale, evaluating the scale-related parameters for the process to provide comprehensive procedure to manufacturing.
13. Discuss on experimental plans and periodically report the results and conclusions to the team leader, to enable continuous flow of information.
14. Responsible to maintain the infrastructure and resources of R&D downstream for effective utilisation and working condition.
15. Coordination on preparation of relevant documentation (e.g. protocols, reports, operating procedures, TTD, etc.) both inter and intra departments.
16. Responsible to draft scientific reports using the process data, protocols and plan for the activity.
17. Work as team and verify data generated at lab to provide appropriate conclusions.
18. Responsible for effective inter and intra departmental communication.
19. Enhance knowledge through reading literature, scientific journals and being update on recent pharma and biotechnology product development and manufacturing trend.
20. Gain knowledge on the subject for an employee based on his/her job profile such as (not limited to) Basics of cGMP, GDP, Data Integrity, GLP, Microbiology, or any other GxP Training, as applicable.
21. Ensure that all documentation is accurate, timely, legible, complete and permanent (ALCOA principle).
22. Ensure all R&D mandatory training completed within timeline given before execute activity in R&D.
23. Ensure adherence of safe work practices in R&D and interface with EHS team for respective meetings, training, address, implementation and compliance.
24. Employees who are involved in GMP activities should undergo a mandatory cGMP training.
25. Ensure that all mandatory basic training is completed once in a year.
26. Ensure compliance and document control for Safety related activities.
27. To coordinate and manage material reservation and cross functional communication for raw material and consumable request.
28. To maintain physical raw material and consumable stock at RND and maintain the material log for stock monitoring.
29. To perform monthly material stock check, log review and monthly updates to R&D-functional team.
30. To create PR for common item and GRN creation for services rendered by RND.
31. To perform periodic review for PR/PO creation, delivery status and any issues on procurement and supply with SCM.Key Responsibilities1. Responsible to involve in downstream process transfer from Biocon India to Biocon Malaysia for downstream unit operations.
2. Responsible to involve in process transfer from R&D to manufacturing facility.
3. Responsible for good documentation practice and continuous practice & implementation of quality and EHS systems.
4. Fulfil the training needs identified for effective execution of job function.
5. Perform process familiarisation and establishment at Biocon Malaysia for process received from Biocon India.
6. Involve in root cause investigation and CAPA identification for deviations observed at manufacturing scale operations and methodology to avoid potential deviations.
7. Perform experimental studies as part of investigation and troubleshooting to support manufacturing operations.
8. Perform lab and pilot scale validations.
9. Conduct process improvements, process optimization, and evaluation of alternate techniques for the process to reduce overall COGs.
10. Discuss on experimental plans and periodically report the results and conclusions to the team leader/supervisor, to enable continuous flow of information.
11. Responsible for data monitoring of manufacturing scale batches and perform data analysis to evaluate trends.
12. Identify the requirements for process transfer to manufacturing scale, evaluating the scale-related parameters for the process to provide comprehensive procedure to manufacturing.
13. Discuss on experimental plans and periodically report the results and conclusions to the team leader, to enable continuous flow of information.
14. Responsible to maintain the infrastructure and resources of R&D downstream for effective utilisation and working condition.
15. Coordination on preparation of relevant documentation (e.g. protocols, reports, operating procedures, TTD, etc.) both inter and intra departments.
16. Responsible to draft scientific reports using the process data, protocols and plan for the activity.
17. Work as team and verify data generated at lab to provide appropriate conclusions.
18. Responsible for effective inter and intra departmental communication.
19. Enhance knowledge through reading literature, scientific journals and being update on recent pharma and biotechnology product development and manufacturing trend.
20. Gain knowledge on the subject for an employee based on his/her job profile such as (not limited to) Basics of cGMP, GDP, Data Integrity, GLP, Microbiology, or any other GxP Training, as applicable.
21. Ensure that all documentation is accurate, timely, legible, complete and permanent (ALCOA principle).
22. Ensure all R&D mandatory training completed within timeline given before execute activity in R&D.
23. Ensure adherence of safe work practices in R&D and interface with EHS team for respective meetings, training, address, implementation and compliance.
24. Employees who are involved in GMP activities should undergo a mandatory cGMP training.
25. Ensure that all mandatory basic training is completed once in a year.
26. Ensure compliance and document control for Safety related activities.
27. To coordinate and manage material reservation and cross functional communication for raw material and consumable request.
28. To maintain physical raw material and consumable stock at RND and maintain the material log for stock monitoring.
29. To perform monthly material stock check, log review and monthly updates to R&D-functional team.
30. To create PR for common item and GRN creation for services rendered by RND.
31. To perform periodic review for PR/PO creation, delivery status and any issues on procurement and supply with SCM.Educational QualificationsRequired Education Qualification: Bsc
Required Experience: 1 - 5 years