Executive - Biopharma Drug Substance Upstream

Biocon Sdn Bhd; Johor Bahru; On-site; MYR 100,000 - 167,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Insurance coverage for family

Annual leave

Casual leave

In-house gym

Job summary

Biocon Sdn Bhd seeks an Executive for Upstream Drug Substance operations. The role centers on executing process operations, monitoring batch performance, and maintaining real-time production records within a GMP environment.

You will investigate deviations, implement corrective actions, and ensure timely equipment maintenance in collaboration with maintenance and automation teams. A strong foundation in biotech/bioprocess is essential.

Qualifications

• Bachelor-level degree in biotechnology/chemical/bioprocess/biochemistry or equivalent.

Responsibilities

• Execute and monitor process operations as per standard procedures.
• Maintain production records (BMRs) in real time.
• Report non-conformities and deviations, investigate root causes, and implement corrective actions.
• Coordinate with Engineering Maintenance and Instrumentation teams for equipment uptime.
• Prepare and revise necessary documents and SOPs as required.
• Manage process orders and inventory in SAP.
• Plan raw materials and procurement for each batch.

Skills

Process operations

Batch monitoring

Documentation

Quality systems

Cross‑functional coordination

Education

Bachelor’s Degree in Biotechnology

Bachelor’s Degree in Chemical Engineering

Bachelor’s Degree in Bioprocess Engineering

Bachelor’s Degree in Biochemistry

Tools

SAP

Job description

Executive - Biopharma Drug Substance Upstream

1. To execute the process operations and monitor the batch performance as per standard procedures in the plant

2.To practice and monitor the compliance with the requirements of Good Manufacturing

3. To execute the instructions relating to production operations

4. Follow the established procedures and policies of the company pertaining to EHS management system and compliance.

5. To update the BMRs and other production records at real time

6. Maintenance and utilization of raw materials as per production requirement

7. Reporting of Non-Conformities and deviation observed during the process, investigating, arriving corrective and preventive action and ensuring the implementation of the same.

8. To ensure timely maintenance of PDS Upstream premises and equipments in co-ordination with Engineering Maintenance and Instrumentation and Automation department.

9. To follow timely and effective communication and report process and facility related issues to appropriate higher levels

10. To execute Qualification and Validation protocols as per plan

11. To participate in Commissioning and Qualification activities

12. To prepare and revise necessary documents as and when required

13. Responsible for Process order and Inventory management in SAP system.

14. Raw material planning for the batch and procurement from the warehouse, maintenance and utilization as per production requirement.

15. Managing and closure of OOS, change management and deviation.

16. Data owner for process equipment used in day-to-day activity

Bachelor’s Degree in Biotechnology, Chemical Engineering, Bioprocess Engineering, Biochemistry or equivalent field.

4 - 11 years of hands‑on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations.

AboutTheBenefits

AtBiocon,you’ll receive a competitive salary and robust benefits package—medical, dental, and insurance coverage that extends to you and your family. Enjoy annual and casual leave, complimentary duty meals, access to a in‑house gym/sportsroom, and exceptional opportunities for career advancement.

Pharmaceuticals, Biotechnology & Medical Devices 101-1,000 employees

In 2012, with more than 40 years of success behind it, Biocon, India's largest biotech company set up their first overseas plant in Johor Bahru, Malaysia – Asia’s largest integrated Insulin manufacturing facility. With an investment of about USD 275 million, it is the highest foreign investment in Malaysia’s biotech sector till date and currently employs about 650 professionals in a state‑of‑the‑art facility.

The attached document speaks about the journey and the many challenges and milestones encountered along the way. It talks of the Human Capital strategy of the company and how the Malaysia story is embedded in the same.

There were several steps which led to the success and many of them were differentiated with innovative ideas and sharp business acumen.

Biocon Malaysia offers an excellent career opportunity for biotech professionals.

If you want to be a part of a Company that constantly creates history and consistently earns more accollades for its innovations and other significant accomplishments and contributions, then we invite you to be a part of the BIOCON FAMILY!

In 2012, with more than 40 years of success behind it, Biocon, India's largest biotech company set up their first overseas plant in Johor Bahru, Malaysia – Asia’s largest integrated Insulin manufacturing facility. With an investment of about USD 275 million, it is the highest foreign investment in Malaysia’s biotech sector till date and currently employs about 650 professionals in a state‑of‑the‑art facility.

The attached document speaks about the journey and the many challenges and milestones encountered along the way. It talks of the Human Capital strategy of the company and how the Malaysia story is embedded in the same.

There were several steps which led to the success and many of them were differentiated with innovative ideas and sharp business acumen.

Biocon Malaysia offers an excellent career opportunity for biotech professionals.

If you want to be a part of a Company that constantly creates history and consistently earns more accollades for its innovations and other significant accomplishments and contributions, then we invite you to be a part of the BIOCON FAMILY!

Registration No. 201101002193 (930330-U).