Production Shift Incharge

2 weeks ago

Vizag, Andhra Pradesh, India Laurus Bio Full time ₹ 5,00,000 - ₹ 15,00,000 per year

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.

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