About Company: Top 10 Pharma company having USFDA approved facilty for API, Formulation and Biologics business.

Position: DGM - Sterile API Production(Dry Powder Injection)

Reporting To: Site Head
Department: Production
Location: USFDA-Regulated Pharmaceutical Manufacturing Facility

Job Purpose

To lead and manage sterile dry powder injectable manufacturing operations, ensuring compliance with USFDA cGMP requirements, product quality, operational efficiency, and timely achievement of production targets.

Key Responsibilities

- Lead end-to-end production operations for sterile dry powder injectable products.
- Ensure manufacturing activities comply with USFDA, cGMP, WHO-GMP, and applicable regulatory requirements.
- Ensure strict adherence to aseptic processing practices, contamination control strategy (CCS), cleanroom discipline, and environmental monitoring requirements.
- Oversee batch manufacturing, filling, lyophilization (where applicable), and associated production activities.




- Ensure compliance with BMRs, SOPs, process validation, and valuable documentation practices.
- Drive deviation investigations, CAPA, change controls, and audit readiness in coordination with QA.
- Ensure successful execution of media fills, process validation, and other applicable qualification activities.
- Monitor production performance, yields, productivity, equipment utilization, and manufacturing costs.
- Coordinate with QA, QC, Microbiology, Engineering, Warehouse, and other cross-functional departments.
- Lead, train, and develop production teams while building a strong quality and compliance culture.
- Participate in USFDA inspections and ensure timely closure of production-related observations.
- Drive continuous improvement, operational excellence, and EHS compliance.

📌 DGM - Sterile API Production (India)
🏢 Talental Consultings
📍 India