Job Description

Technical & Process Leadership

• Provide leadership in solid-phase and liquid-phase peptide synthesis (SPPS/LPPS), including hybrid technologies and advanced platforms such as molecular hiving (preferred).
• Drive process development, optimization, and technology transfer for peptide APIs.
• Lead scale-up activities, ensuring robustness, reproducibility, and equivalence across batch sizes.
• Review and approve manufacturing strategies from Stage-I to final API
  • Oversee end-to-end peptide manufacturing including, Synthesis (Automated Synthesizers) , Cleavage , Purification (Preparative Chromatography) and Lyophilization

2. Manufacturing Operations

• Ensure smooth plant operations with optimal utilization of resources and adherence to production plans.
• Monitor utilities (steam, vacuum, chilled water, etc.) and ensure uninterrupted operations.

3. Regulatory & Compliance

• Ensure full compliance with cGMP, USFDA, and global regulatory requirements
  • Provide oversight on DMF preparation, review, and lifecycle management -Review and approve of Batch Manufacturing Records (BMR) , Deviations, CAPA, Change Controls

  • Ensure audit readiness and lead interactions during regulatory inspections.

4. Equipment & Engineering Interface -Lead URS preparation and qualification (DQ/IQ/OQ/PQ) of new equipment. Ensure effective coordination with Engineering for, any Breakdown management ,Preventive maintenance , Equipment reliability improvement

5. Cross-Functional Coordination

• Collaborate with QA, QC , Warehosue and R&D for process improvements and scale-up strategies

6. Material & Inventory Management - Ensure proper handling, storage, reconciliation, and documentation of , Raw materials , Intermediates and API . also Monitor and optimize inventory of consumables and critical materials.

7. Quality & Documentation Oversight - Ensure accuracy, completeness, and compliance of all GMP documentation. Review manufacturing and operational records. Oversee in-process sampling and testing practices.

8. EHS & GMP Culture- Ensure strict adherence to safety protocols, PPE usage, and environmental guidelines Oversee handling and disposal of hazardous materials.Promote a strong GMP, quality, and safety culture across the peptide block.

Exp- 15yrs