Associate Director External Manufacturing

Job Advert : Associate Director, External Manufacturing

Location : Dublin

Remote / Hybrid based in Ireland

About the Role

We're seeking an experienced and driven Associate Director, External Manufacturing to provide technical leadership across a global external manufacturing network. This position plays a key role in supporting new product introductions, technology transfers, and the ongoing optimisation of drug product and packaging operations.

Key Responsibilities

Lead technical oversight of external drug product and packaging processes.

Support CMO selection, onboarding, and tech transfer activities.

Oversee packaging qualifications (IQ / OQ / PQ / PPQ) and implementation of new technologies.

Contribute to packaging development, validation and risk management initiatives.

Ensure compliance with GMP and global regulatory requirements.

Collaborate cross-functionally to drive performance, troubleshoot issues, and enhance operational efficiency.

Support regulatory submissions and lead or contribute to investigations and CAPA management.

Requirements

Bachelor's or Master's degree in Engineering or a related scientific discipline.

Extensive experience in pharmaceutical drug product and packaging operations, including oral solid dosage, vial and syringe filling.

Deep knowledge of GMP regulations and packaging development for commercial products.

Proven track record in technical leadership, CMO management, and process improvement.

Strong communication, technical writing, and problem-solving capabilities.