27 Aug
|
Pardha Constrcution
|
Alimpur
27 Aug
Pardha Constrcution
Alimpur
Experience: 5–9 Years
Function: Downstream Processing / RP Chromatography / Production
Industry: Pharmaceutical / API
Reporting To: Senior Manager / Head – Production
Role Summary
Responsible for execution and supervision of Reverse Phase (RP) chromatography operations in pharmaceutical/API manufacturing, ensuring production targets, product purity, yield, GMP compliance, safety, and timely batch completion.
Key ResponsibilitiesRP Chromatography Operations
- Execute and supervise Reverse Phase chromatography purification batches.
- Operate and monitor preparative/process-scale chromatography systems.
- Optimize and monitor mobile phase, solvent composition, flow rate, loading, gradient, pressure, and other process parameters.
- Ensure consistent product purity, recovery, and yield.
- Monitor chromatographic profiles and identify abnormalities during processing.
Column Operations
- Perform/support column packing, unpacking, cleaning, regeneration, and storage.
- Monitor column performance, pressure, resolution, efficiency, and lifetime.
- Troubleshoot column-related problems such as channeling, high back pressure, poor resolution, and loss of efficiency.
Production & Batch Execution
- Execute manufacturing activities according to approved BMR/BPR, SOPs, and GMP requirements.
- Monitor batch progress, yield, recovery, cycle time, and solvent consumption.
- Complete manufacturing documentation accurately and on time.
- Coordinate with QA, QC, Engineering, Warehouse, and Planning.
Process Troubleshooting
- Investigate issues related to:
- Low recovery
- Poor resolution
- Purity failures
- High pressure
- Peak broadening
- Product loss
- Column performance
- Solvent/mobile-phase issues
- Support root-cause investigations and CAPA implementation.
Process Improvement
- Improve RP purification yield, purity, throughput, and cycle time.
- Reduce solvent consumption and process losses.
- Support scale-up and process optimization activities.
- Participate in continuous
📌 Senior Manager – Reverse Phase (Alimpur)
🏢 Pardha Constrcution
📍 Alimpur