Director, Drug Substance Commercialisation & Development
Core
Strategic and technical leadership for the end-to-end commercialisation, process development, scale-up, and lifecycle management of clinical and commercial active pharmaceutical ingredients (APIs) at the Ballydine site.
Role type
Director, Drug Substance Commercialisation & Development
Builds
Clinical and commercial API supply chains, scaled manufacturing processes, and validated production campaigns.
Domain
Pharmaceutical manufacturing / Chemical Engineering / Process Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process chemistry, Chemical engineering, API commercial manufacture, cGMP operations, Validation strategies, Financial management, Regulatory compliance, Risk management, Team leadership, Strategic planning
Preferred skills
Manufacturing
Technologies
DeltaV, Electronic batch records
Responsibilities
Define and implement Drug Substance commercialisation strategy; Direct process development, optimisation, and scale-up activities; Lead pre-PPQ, PPQ, and commercial production campaigns; Oversee process monitoring, deviation investigations, and cleaning strategies; Lead transfers of processes to internal sites and external partners; Build and develop a team of technical leaders and specialists.
Seniority
Director, strategic leadership & hands-on technical oversight
