Associate Specialist, Drug Product Commercialisation, …, Dublin

Associate Specialist, Drug Product Commercialisation, Development&Supply

An amazing opportunity has arisen for an Associate Specialist in the Commercialisation, Development and Supply (CDS) group. The group is responsible for process development of Active Pharmaceutical Ingredients (API), Oral Solid Dosage (OSD) forms and potent products from Phase IIb through regulatory filings, process validation, and into the first few years of commercial launch.

Responsibilities

Plan, conduct, evaluate and interpret process development studies, including scale‑up, drug product characterization, and design space development.

Process validation.

Clinical and formal stability batch manufacture.

Lead and participate in cross‑functional teams to carry out Quality Risk Assessments, Quality Investigations, Safety Assessments and Change Control Process.

Problem‑solving skills and knowledge of Quality by Design concepts, risk‑based approaches to development, design of experiments, and process modelling.

Support commercial supply activities such as manufacturing and cleaning recipe and documentation preparation.

Technical support to manufacturing and cleaning campaigns.

Troubleshoot, investigate and document process issues and deviations.

Identify and implement process improvement and optimization opportunities.

Other responsibilities include data analysis, technology evaluation, SOP authorship, and compliance with applicable safety and current GMP practices.

Qualifications

Minimum 1–3 years relevant experience in Oral Solid Dosage manufacturing.

Strong oral communication skills.

Proficiency in technical writing.

Ability to work independently and deliver work tasks on time.

Bachelor’s or postgraduate degree in Chemical or Process Engineering or a science‑related discipline.

As an equal‑opportunity employer, we are proud to embrace the value of bringing diverse, talented and committed people together.

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