Executive/Senior Executive - Project Management - (API/CDMO)

Hetero; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Hetero in Hyderabad (India) seeks a Project Management Professional with 3 to 6 years of API/CDMO experience to steer projects from development through commercial manufacturing. The role requires coordinating with cross‑functional teams and customers across Technology Transfer, production, QA and QC functions.

The successful candidate will manage timelines, risks, and documentation, ensuring adherence to cGMP, ICH, Data Integrity and global regulatory requirements while driving process

Qualifications

• 3–6 years of experience in API/CDMO pharma.
• Exposure to Technology Transfer (TSD), Production, QA, or QC.
• Ability to manage projects from development through commercial manufacturing.
• Coordinate with cross‑functional teams and customers.

Responsibilities

• Manage end‑to‑end project activities from technology transfer to commercial manufacturing.
• Coordinate technology transfer, process scale‑up, engineering batches, validation batches, and commercial production.
• Collaborate with R&D, Production, QA, QC, Engineering, Supply Chain, Regulatory Affairs, and customers to ensure timely project execution.
• Prepare and monitor project timelines, milestones, deliverables, and risk mitigation plans.
• Support process validation, cleaning validation, equipment qualification, and technology transfer documentation.
• Coordinate customer technical discussions, project review meetings, and manufacturing readiness activities.
• Track project progress and provide regular status updates to customers and management.
• Ensure compliance with cGMP, ICH guidelines, Data Integrity, EHS, and global regulatory requirements.
• Review project‑related documentation, deviations, CAPA, change controls, and validation reports.
• Support customer audits, regulatory inspections, and internal quality audits.
• Drive continuous improvement initiatives for project execution, process optimization, and operational excellence.

Skills

Project Management

Technology Transfer

API Production

Quality Assurance

Quality Control

Job description

Job Summary

We are seeking a highly motivated Project Management Professional with 3 to 6 years of experience in the API/CDMO pharmaceutical industry. The ideal candidate should have exposure to Technology Transfer (TSD), Production, Quality Assurance (QA), or Quality Control (QC) and be capable of managing projects from development through commercial manufacturing while coordinating with cross‑functional teams and customers.

Key Responsibilities

• Manage end‑to‑end project activities from technology transfer to commercial manufacturing.
• Coordinate technology transfer, process scale‑up, engineering batches, validation batches, and commercial production.
• Collaborate with R&D, Production, QA, QC, Engineering, Supply Chain, Regulatory Affairs, and customers to ensure timely project execution.
• Prepare and monitor project timelines, milestones, deliverables, and risk mitigation plans.
• Support process validation, cleaning validation, equipment qualification, and technology transfer documentation.
• Coordinate customer technical discussions, project review meetings, and manufacturing readiness activities.
• Track project progress and provide regular status updates to customers and management.
• Ensure compliance with cGMP, ICH guidelines, Data Integrity, EHS, and global regulatory requirements.
• Review project‑related documentation, deviations, CAPA, change controls, and validation reports.
• Support customer audits, regulatory inspections, and internal quality audits.
• Drive continuous improvement initiatives for project execution, process optimization, and operational excellence.

Required Skills

• Experience in Project Management, Technology Transfer (TSD), API Production, Quality Assurance, or Quality Control.
• Strong understanding of API manufacturing processes and commercial operations.
• Knowledge of cGMP, ICH, Data Integrity, WHO-GMP, USFDA, EU GMP, MHRA, PMDA, and other regulatory requirements.
• Experience in process validation, analytical method transfer, equipment qualification, and project documentation.
• Knowledge of deviations, CAPA, change control, risk assessment, and quality systems.
• Strong analytical, problem‑solving, and decision‑making skills.
• Excellent communication, stakeholder management, and cross‑functional coordination abilities.
• Ability to manage multiple projects and deliver within defined timelines.