Upstream Fermentation Operations Lead

Biocon Sdn Bhd; Gelang Patah; On-site; MYR 180,000 - 240,000; Full time

Job summary

Biocon Sdn Bhd in Malaysia is seeking an Assistant Manager, Upstream Fermentation, to lead commercial-scale fermentation operations, oversee media preparation, seed culture, fermentation, harvest coordination, and GMP documentation.

You will monitor critical process parameters (pH, DO, temperature, aeration), ensure on-time batch execution, and drive continuous improvements while upholding cGMP, EHS, and regulatory compliance, coordinating with QA/QC, Engineering, Warehouse and MSAT teams.

Qualifications

• 6-10 years of upstream Fermentation manufacturing experience.
• Minimum 3-5 years hands-on in large-scale fermentation.
• Exposure to cGMP manufacturing and quality systems.

Responsibilities

• Execute and supervise upstream fermentation activities per Batch Manufacturing Records and SOPs.
• Monitor critical parameters such as pH, DO, temp, aeration, and feed strategies.
• Coordinate with QA, QC, Engineering, Warehouse and MSAT for batch execution.
• Review batch records and investigate deviations, CAPAs, changes, OOS/OOT.

Skills

Upstream Fermentation Ops

Seed Train Management

Process Monitoring

GMP Documentation Review

Deviation & CAPA Management

SAP/MES Systems

Cross-Functional Collaboration

Education

Bachelor's/Master's in Biotechnology/related field

Tools

SAP/MES Systems

Job description

Biocon Sdn Bhd in Malaysia is seeking an Assistant Manager, Upstream Fermentation, to lead commercial-scale fermentation operations, oversee media preparation, seed culture, fermentation, harvest coordination, and GMP documentation.

You will monitor critical process parameters (pH, DO, temperature, aeration), ensure on-time batch execution, and drive continuous improvements while upholding cGMP, EHS, and regulatory compliance, coordinating with QA/QC, Engineering, Warehouse and MSAT teams.