Assistant Manager, Upstream Fermentation (Fermentation Engineer)

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

Assistant Manager, Upstream Fermentation (Fermentation Engineer)

The Assistant Manager – Upstream Fermentation is responsible for planning, executing, and monitoring upstream manufacturing operations, including media preparation, seed cultivation, fermentation, harvest coordination, and associated GMP documentation. The role ensures production targets are achieved safely, efficiently, and in compliance with cGMP, EHS, and regulatory requirements while driving process improvements and team development.

Key Responsibilities

Manufacturing Operations

Execute and supervise upstream fermentation activities as per approved Batch Manufacturing Records (BMRs), SOPs, and process instructions.

Monitor critical process parameters including pH, DO, temperature, aeration, agitation, and feed strategies.

Ensure adherence to production schedules and timely completion of manufacturing campaigns.

Coordinate with downstream, QA, QC, Engineering, Warehouse, and MSAT teams for seamless batch execution.

Track batch performance and analyze trends to improve productivity and batch success rates.

GMP & Quality Compliance

Ensure compliance with cGMP, Data Integrity, and company quality procedures.

Review and verify batch records, logbooks, and electronic documentation.

Initiate, investigate, and support closure of deviations, CAPAs, change controls, OOS, and OOT events.

Support internal audits, customer audits, and regulatory inspections.

Participate in management reviews and continuous improvement initiatives.

Equipment & Facility Management

Ensure operational readiness of fermenters, media preparation vessels, seed systems, and utilities.

Coordinate preventive maintenance, calibration, qualification, and validation activities.

Support troubleshooting of process and equipment-related issues to minimize production downtime.

Ensure proper cleaning, sanitization, and maintenance of manufacturing equipment.

Qualifications

Education

Bachelor's or Master's Degree in Biotechnology, Microbiology, Biochemical Engineering, Chemical Engineering, Life Sciences, or related discipline.

Experience

6-10 years of experience in upstream Fermentation manufacturing.

Minimum 3-5 years of hands-on experience in large-scale fermentation operations.

Exposure to cGMP manufacturing, qualification/validation activities, and quality systems.

• Upstream Fermentation Operations
• Seed Train Management
• Process Monitoring & Troubleshooting
• GMP Documentation Review
• Deviation, CAPA & Change Control Management
• SAP/MES Systems
• Strong Communication and Cross-Functional Collaboration

Ideal Profile: A technically strong fermentation professional capable of leading commercial-scale upstream manufacturing operations, ensuring GMP compliance, driving operational excellence, and developing high-performing teams.

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.

Registration No. 201101002193 (930330-U).