Assistant Manager / Manager - Bioprocess

Job Title:

Department:

Reporting To:

Location:

Educational Qualification:

Experience Required

1. Role Summary:

The Bioprocess AM / Manager will be responsible for planning, executing, and monitoring fermentation operations to ensure consistent batch performance, optimum yields, and compliance with regulatory, quality, and safety standards. The role demands strong technical expertise in fermenter operations, process utilities, and data-driven decision-making, along with leadership capabilities for effective team management and coordination with cross-functional departments.

2. Key Responsibilities:

• Plan, schedule, and supervise fermentation batches in alignment with production targets.
• Oversee day-to-day operations of fermenters and associated upstream systems.
• Troubleshoot process and hardware issues in fermenters and related utilities.
• Coordinate with maintenance, utilities, QA, and planning teams for seamless operations.
• Ensure adherence to GMP, safety, and documentation standards.
• Review and approve batch records, logbooks, and deviation reports.
• Monitor key process parameters to ensure consistency and yield optimization.
• Lead and mentor the bioprocess team for skill development and performance improvement.
• Prepare and present Monthly MIS reports in management review meetings.
• Support process validation, scale-up, and continuous improvement initiatives.

3. Technical Skills:

• In-depth understanding of fermenter design, automation, and process control.
• Working knowledge of upstream utilities – air compressors, steam systems, CIP/SIP systems, chillers, and media preparation.
• Familiarity with PLC/SCADA systems for process monitoring and troubleshooting.
• Proficiency in SAP (Production Module) and SAP Master Recipe Management.
• Ability to analyze and interpret process data for continuous improvement.
• Competence in MS Excel, Word, and PowerPoint for data reporting and presentations.

4. Behavioral Competencies:

• Strong leadership and team-handling abilities.
• Excellent communication and coordination skills across departments.
• Analytical thinking and proactive problem-solving approach.
• High accountability, integrity, and attention to detail.

5. Key Performance Indicators (KPIs):

• Achievement of monthly production and yield targets.
• Batch success rate and reduction in deviations.
• On-time completion of MIS and reporting requirements.
• Compliance with GMP and audit standards.
• Team productivity and skill development metrics.