Key Responsibilities:
Technical & Operational Responsibilities:
- Optimize classical microbial fermentation processes for high cell density and metabolite production using bacteria, yeast, or fungi (e.g., E. coli, Bacillus, Saccharomyces, Streptomyces).
- Ensure production targets (volume, yield, quality, and timelines) are consistently achieved.
- Troubleshoot upstream process deviations, contamination, or yield drops.
- Collaborate with R&D and Tech Transfer teams for scale-up and commercial execution of new strains or processes.
- Evaluate and implement process improvements, automation, and cost-saving initiatives.
- Review and ensure accurate documentation (batch records, SOPs, deviation reports, change controls).
Compliance & Quality:
- Ensure operations are in full compliance with cGMP, regulatory, and EHS requirements.
- Support regulatory audits (USFDA, EMA, WHO, etc.) and customer inspections.
- Participate in investigations (OOS/OOT, deviations) and implement CAPAs related to upstream activities.
Team Leadership & Coordination:
- Lead, mentor, and develop a team of production officers, operators, and shift engineers.
- Ensure adequate training of team members on fermentation operations and GMP.
- Coordinate closely with downstream, QA, maintenance, and warehouse functions for smooth operations.
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