PDL Head

1. Position Overview

The PDL Head (Product Development & Lifecycle Head) in API Manufacturing is responsible for overseeing the complete lifecycle of API products—from technology transfer, scale-up, and process optimization to routine production support. The role ensures efficient manufacturing processes, regulatory compliance, cost optimization, and continuous improvement across API blocks/units.

2. Key ResponsibilitiesA. Production & Process Leadership

• Lead end-to-end production planning, scheduling, and execution of API batches.
• Ensure manufacturing targets for quantity, quality, and timelines are achieved.
• Oversee process optimization, yield improvement, and troubleshooting.
• Coordinate with engineering to ensure equipment readiness and maintenance.

B. Technology Transfer & Scale-Up

• Drive successful technology transfer (TT) from R&D/PDL to plant.
• Review and approve scale-up protocols, batch manufacturing records (BMR), and process parameters.
• Ensure smooth transition of new APIs or intermediates into commercial production.

C. Compliance & Documentation

• Ensure compliance with cGMP, ICH, regulatory, and safety standards.
• Oversee preparation, revision, and control of SOPs, BMRs, BPRs, and validation protocols.
• Support regulatory inspections (USFDA, EMA, MHRA, WHO, state FDA).

D. Quality & Continuous Improvement

• Work collaboratively with Quality Control and Quality Assurance to maintain product quality.
• Lead root-cause analysis, deviation investigations, CAPA, and change controls.
• Promote Lean manufacturing, Six Sigma, and energy optimization initiatives.

E. Team Leadership & Training

• Manage and mentor PDL/production teams, supervisors, and shift in-charges.
• Identify skill gaps and plan training for process safety, documentation, and equipment handling.
• Foster a culture of discipline, teamwork, and continuous improvement.

F. Cost & Resource Management

• Optimize production cost, raw material consumption, and utilities usage.
• Review and adhere to budgets for manpower, materials, and operating costs.
• Support vendor evaluation and procurement decisions for equipment and materials.

3. Key Skills & Competencies

• Strong knowledge of API/Intermediate manufacturing, cGMP, and regulatory requirements.
• Expertise in technology transfer, scale-up, and process validation.
• Analytical and problem-solving skills; ability to handle complex technical challenges.
• Leadership, planning, and team management abilities.
• Knowledge of equipment such as reactors, centrifuges, dryers, and handling hazardous chemicals.
• Understanding of process safety (HAZOP, risk assessment).

* Candidates with 15–18 years of experience in API manufacturing.

* Preference: Male candidates

Job Type: Full-time

Pay: ₹1,000, ₹1,500,000.00 per year

Benefits:

• Health insurance
• Provident Fund

Work Location: In person