Assoc. Director, Drug Substance Commercialisation

As a member of the Commercialisation Leadership Team, you are responsible for strategy development and implementation.

Lead technical support for commercialisation activities across clinical and commercial production, including multiple processes and process steps.

Oversee evaluation of raw materials, process fits, optimisation of chemical API routes, and development for scale-up.

Approval of campaign preparation and follow-ups, safety and environmental reviews, batch record reviews, and ensure regulatory and validation compliance.

Conduct process monitoring and time cycle analysis, lead deviation investigations and resolution, and define cleaning processes.

Provide process leadership to production campaigns (pre-PPQ and commercial).

Director, Drug Substance Commercialisation

The successful candidate will manage the provision of technical support for the introduction and production of clinical and commercial active pharmaceutical ingredients (APIs).

You will lead process development and scale-up activities, drive process improvements, and provide technical expertise to resolve significant processing issues.

This role combines hands-on technical leadership with people and project management responsibilities to ensure safe, compliant, and efficient production.

Our Ballydine site is the primary commercialisation facility within the network and the hub where new processes are scaled and brought to commercial manufacture.

This site supports the introduction and production of clinical and commercial APIs and the transfer of processes and technologies across internal sites and external partners.