Production Shift Incharge - Downstream Processing (DSP)

Job Summary:

The Production Shift In-Charge DSP is responsible for leading all downstream processing operations during the assigned shift to ensure consistent, efficient, and GMP-compliant production of biological products (e.g., monoclonal antibodies, vaccines, recombinant proteins). The role involves supervising the purification process, managing manpower, ensuring equipment readiness, and maintaining quality and safety standards.

Role & responsibilities

Key Responsibilities:

1. Shift Operations Management

• Supervise all downstream production activities, including harvest, filtration, chromatography, ultrafiltration/diafiltration (UF/DF), and formulation.
• Ensure batch manufacturing records (BMRs) are followed strictly as per approved procedures and cGMP guidelines.
• Monitor process parameters (flow rates, pressures, conductivity, pH, temperature, etc.) and record data accurately.
• Perform in-process checks and ensure timely sampling and coordination with the QC team.
• Oversee batch changeovers and line clearances between operations.

2. Team Leadership & Training

• Lead, train, and supervise production executives, operators, and contract staff during the shift.
• Allocate manpower effectively to ensure smooth workflow and timely batch execution.
• Conduct on-the-job training for team members on GMP, safety, and equipment operation.

3. Equipment & Process Management

• Ensure readiness, cleaning, and sterilization of all DSP equipment (e.g., chromatography skids, TFF systems, centrifuges, filtration units, mixers).
• Oversee CIP (Clean-in-Place) and SIP (Sterilize-in-Place) activities.
• Coordinate with Engineering for equipment maintenance, calibration, and troubleshooting.
• Review equipment logs and ensure timely updates in line with GMP compliance.

4. Documentation & Compliance

• Review and verify batch records, logbooks, and cleaning records for accuracy and completeness.
• Ensure compliance with cGMP, GDP (Good Documentation Practices), EHS (Environment, Health & Safety), and company quality standards.
• Identify and report deviations, non-conformances, and assist in root cause analysis and CAPA implementation.
• Support internal and external audits and provide necessary process documentation.

5. Coordination & Communication

• Collaborate with Upstream (USP), QA, QC, Warehouse, and Engineering teams for coordinated production activities.
• Communicate critical process issues, equipment alarms, or safety incidents promptly to the Production Manager.
• Participate in daily production review meetings and contribute to process optimization initiatives.

Preferred candidate profile

Key Competencies:

• Leadership and team management.
• Strong analytical and troubleshooting abilities.
• Excellent communication and documentation skills.
• Focus on quality, safety, and regulatory compliance.
• Ability to work effectively in a 247 shift environment.