Assistant Manager, Upstream Fermentation (Fermentation Engineer)

Position Purpose

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.

Key Skills & Competencies

• Upstream Fermentation Operations
• Seed Train Management
• Media Preparation & Sterilization
• Process Monitoring & Troubleshooting
• GMP Documentation Review
• Deviation, CAPA & Change Control Management
• SAP/MES Systems
• Team Leadership & People Management
• Data Analysis & Continuous Improvement
• 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.