Job Description

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: ₹1,000,000.00 - ₹1,500,000.00 per year

Benefits:

Health insurance Provident Fund
Work Location: In person