Senior Associate & Assistant Manager - Drug Substance Upstream

Biocon Sdn Bhd; Johor Bahru; On-site; MYR 110,000 - 170,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Insurance coverage for family

Annual leave

Casual leave

In-house gym/sports room

Duty meals

Career advancement opportunities

Job summary

Biocon Sdn Bhd in Johor Bahru is seeking a Senior Associate & Assistant Manager - Drug Substance Upstream to ensure smooth process operations, monitor batch performance, and maintain GMP/EHS compliance in a busy biopharma plant.

The role requires updating production records in real time, managing SAP-based material planning, and supporting qualification/validation activities. 4–11 years of hands-on DS manufacturing experience and relevant degree are essential for this position.

Qualifications

• Bachelor’s degree in biotech/related field is required.
• 4–11 years of hands-on experience in biopharmaceutical or drug substance manufacturing or related process operations.
• Experience with GMP/compliance and EHS requirements preferred.

Responsibilities

• Execute process operations and monitor batch performance.
• Ensure compliance with GMP and EHS requirements.
• Update BMRs and production records in real time.
• Manage raw materials per production needs and SAP inventory.
• Participate in qualification, validation, commissioning activities.
• Coordinate with Engineering Maintenance for equipment upkeep.

Skills

Process operations

GMP awareness

SAP systems

Education

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

Tools

SAP

Job description

Senior Associate & Assistant Manager - 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’llreceiveacompetitivesalaryandarobustbenefitspackage—medical,dental,andinsurancecoveragethatextendstoyouandyourfamily.Enjoyannualandcasualleave,complimentarydutymeals,accesstoanin-housegym/sportsroom,andexceptionalopportunitiesforcareeradvancement.

Unlock job insights

Your application will include the following questions:

• Which of the following statements best describes your right to work in Malaysia?
• What's your expected monthly basic salary?
• Which of the following types of qualifications do you have?
• How many years' experience do you have as an Assistant Manager?
• Do you have experience completing material resource planning (MRP)?
• Do you have experience with inventory management?

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.

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.

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.

Registration No. 201101002193 (930330-U).