Associate Director Engineering

Overview

Associate Director of Engineering will ensure pharma process technology projects are executed with consistent methods and on-time delivery, aligning with Global AH Quality strategy and regulatory requirements.

What you'll do

• Provide project management and technical oversight for drug-product manufacturing site projects involving API changes and process/external supplier changes.
• Manage and support CMO product transfers (CMO-to-CMO, site-to-CMO, and R&D-to-CMO).
• Drive process robustness initiatives and continuous improvement of manufacturing processes to reduce off-specs and cycle times.
• Support life cycle management, technical troubleshooting, and overarching product/material changes.
• Lead or support work on process validation/qualification and change control for drug-products (APIs, excipients, packaging).
• Facilitate cross-functional communication between manufacturing sites and global/local functions (Quality, Supply Chain, Regulatory Affairs, etc.).

What you'll need

• Have at least 10 years of experience in technology/manufacturing in a pharmaceutical/food/fine-chemicals company or in academic experience in pharmaceutical/chemistry departments.
• Have at least 5 years of experience in a regulated environment in pharmaceutical CMO management.
• Have a minimum undergraduate degree in sciences (Engineering, Manufacturing Technology, Pharmaceutical Technology, or Industrial Chemistry preferred).
• Have strong knowledge of GMP requirements or be motivated to acquire it quickly.
• Have a regulatory background requirement or be motivated to acquire it quickly.
• Be willing to travel to production locations up to 40% of the time.
• Be fluent in English.

Details

• Location: Pune, Maharashtra, India.
• Work arrangement: Hybrid.