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 improvement and cost-reduction projects.
GMP & Quality
- Ensure compliance with GMP, SOPs, safety requirements, and data-integrity practices.
- Support deviation, CAPA, change control, and investigation activities.
- Maintain production area and equipment in audit-ready condition.
- Support internal, customer, and regulatory audits.
Validation & Technology Transfer
- Support process validation and cleaning validation activities.
- Participate in equipment qualification.
- Support technology transfer and scale-up from development/pilot to commercial manufacturing.
Team Supervision
- Supervise operators and production staff involved in RP chromatography.
- Allocate manpower and monitor shift activities.
- Train team members on RP chromatography, GMP, SOPs, safety, and troubleshooting.
- Ensure adherence to production schedules.
Candidate Profile
Education: M.Sc / M.Pharm / B.Pharm / B.Tech / M.Tech / Chemistry / Chemical Engineering or relevant qualification.
Experience: 5–9 years of relevant experience in pharmaceutical/API manufacturing, downstream processing, chromatography, or purification.
Must-Have Skills
- Hands-on experience in Reverse Phase (RP) chromatography.
- Experience with preparative/process-scale chromatography.
- Knowledge of column packing and troubleshooting.
- Understanding of solvent/mobile-phase systems and gradient optimization.
- Experience in GMP manufacturing and batch documentation.
- Exposure to deviations, CAPA, change control, and validation.
- Good troubleshooting and analytical skills.
- Ability to supervise production teams and execute batches independently.
Pay: ₹45,000.00 - ₹2,420,412.66 per month
Benefits:
- Food provided
- Health insurance
- Leave encashment
- Provident Fund
Work Location: In person
