Production Manager - Sterile Fermentation

Role Overview

We are looking for a Production Manager skilled in leading sterile fermentation processes within pharmaceutical manufacturing. The successful applicant will head a cross-disciplinary team of engineers and technicians to manage day-to-day sterile fermentation activities while ensuring compliance with regulatory standards and process optimization.

Key Responsibilities

• Lead a team of engineers and technicians in sterile fermentation operations.
• Develop, design, and improve upstream and downstream sterile fermentation parameters.
• Troubleshoot intricate process challenges to enhance yield and operational efficiency.
• Coordinate corrective and preventive actions (CAPA) aligned with cGMP and FDA regulations.
• Manage and integrate process control systems such as PLC, SCADA, and DCS.

Essential Requirements

• Strong knowledge of sterile fermentation concepts and biosafety guidelines.
• Familiarity with regulatory frameworks including FDA standards, HACCP, FMEA, and IQ/OQ/PQ protocols.
• Practical experience in managing manufacturing operations under cGMP standards.
• Ability to oversee technology transfer and ensure process validation (e.g., PPQ, process verification).
• Experience with documentation including SOP development and adherence.
• Prior exposure to cosmetic and detergent industry processes is required.

Candidate Eligibility

Applicants must hold a B.Tech or B.E. degree in Biochemistry or Biotechnology.