Research And Development Manager - Downstream

Biocon Biologics; Johor Bahru; On-site; MYR 42,000 - 60,000; Full time

Job summary

A leading company in the biopharmaceutical sector is looking for a candidate to manage and coordinate R&D activities, support technology transfers, and ensure compliance with safety standards. Successful applicants will possess strong people management skills and knowledge in cGMP and relevant training. This role provides opportunities for personal and team development in a dynamic and compliance-focused environment.

Qualifications

• Knowledge relevant to job profile including cGMP, GDP, Data Integrity, GLP, Microbiology.
• Experience in personnel management and conflict resolution.
• Familiarity with safety and compliance practices.

Responsibilities

• Coordinate pilot scale planning and execution, and manage equipment maintenance.
• Support technology transfer activities from R&D to manufacturing.
• Ensure compliance with documentation and safety practices.

Skills

cGMP

Data Integrity

Microbiology

Job description

Job Description:

1. Coordinate pilot scale planning & execution, equipment, and infrastructure maintenance.
2. Coordinate within the team, inter-functional, and inter-departmental activities for successful completion.
3. Support technology transfer activities from R&D to manufacturing, including drafting transfer documents and participating in CFT discussions.
4. Plan and coordinate experimental studies for investigation and troubleshooting to support manufacturing operations.
5. Involve in people management through planning, guiding, and reviewing activities for task completion.
6. Identify opportunities for personnel and team development through training and development activities.
7. Manage conflict within the team effectively and utilize resources efficiently.
8. Improve team performance and identify training needs to achieve targets.
9. Gain knowledge relevant to the job profile, such as cGMP, GDP, Data Integrity, GLP, Microbiology, or other GxP training as applicable.
10. Ensure employees involved in GMP activities undergo mandatory cGMP training.
11. Complete all mandatory basic training annually.
12. Ensure documentation is accurate, timely, legible, complete, and adheres to ALCOA principles.
13. Adhere to safe work practices in R&D, interface with EHS for meetings, training, and compliance.
14. Facilitate and address internal and external EHS audit requirements.
15. Manage biowaste and scheduled waste in R&D.
16. Ensure compliance and proper documentation for safety-related activities.
17. Identify EHS training needs for R&D employees and ensure compliance.
18. Manage proper chemical handling and storage in R&D.