Principal Scientist

Qualification:

• Master's or PhD

Responsibilities:

1. Responsible to involve in process transfer from R&D to manufacturing facility.
2. Responsible for good documentation practice and continuous practice & implementation of quality and EHS systems in lab.
3. Fulfil the training needs identified for effective execution of job function and continual updation.
4. Perform process familiarisation and establishment at Biocon Malaysia for process received from Biocon India.
5. Involve in root cause investigation and CAPA identification for deviations observed at manufacturing scale operations and methodology to avoid potential deviations.
6. Perform experimental studies as part of investigation and troubleshooting to support manufacturing operations.
7. Perform lab and pilot scale validations, follow-on process characterisation including scale model qualification and reports.
8. Conduct process improvements, process optimization, and evaluation of alternate techniques for the process to reduce overall COGs or alternative materials.
9. Discuss experimental plans and periodically report the results and conclusions to the team leader/supervisor, to enable continuous flow of information.
10. Responsible for data monitoring of manufacturing scale batches and perform data analysis to evaluate trends.
11. Identify the requirements for process transfer to manufacturing scale, evaluating the scale-related parameters for the process to provide comprehensive procedure to manufacturing.
12. Perform, plan and coordinate experimental studies as part of investigation and troubleshooting to support manufacturing operations.
13. Discuss 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. Effectively plan and ensure the resources required for execution and conclusion of study.
18. Work as a team and verify data generated at lab to provide appropriate conclusions.
19. Responsible for effective inter and intra departmental communication.
20. Enhance knowledge through reading literature, scientific journals and being updated on recent pharma and biotechnology product development and manufacturing trends.
21. 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.
22. Ensure that all documentation is accurate, timely, legible, complete and permanent (ALCOA principle).
23. Ensure all R&D mandatory training is completed within the timeline given before executing activity in R&D.
24. Ensure adherence to safe work practices in R&D and interface with EHS team for respective meetings, training, address, implementation and compliance.
25. Employees who are involved in GMP activities should undergo a mandatory cGMP training.
26. Frequency of mandatory basic training is once a year.
27. Ensure compliance and document control for Safety related activities.
28. Coordinate and manage material reservation and cross-functional communication for raw material and consumable requests.
29. Maintain physical raw material and consumable stock at R&D and maintain the material log for stock monitoring.
30. Perform monthly material stock checks, log reviews and monthly updates to the R&D-functional team.
31. Create PR for common items and GRN creation for services rendered by R&D.
32. Perform periodic reviews for PR/PO creation, delivery status and any issues on procurement and supply with SCM.