Director, Drug Substance Commercialisation & Development
Merck & Co., Inc.
Ballydine, Tipperary, Ireland
Hybrid
15+ years process chemistry experience
Api commercial manufacture expertise
Cgmp manufacturing operations knowledge
The successful candidate will provide strategic and technical leadership for the introduction, development, and commercial manufacture of clinical and commercial active pharmaceutical ingredients
Job Summary
The successful candidate will provide strategic and technical leadership for the introduction, development, and commercial manufacture of clinical and commercial active pharmaceutical ingredients.
This role carries end-to-end accountability for Drug Substance commercialisation activities including process development, scale up, validation, and lifecycle management at the Ballydine site.
The position requires leading a team of technical specialists while ensuring safe, compliant, and robust supply aligned with enterprise objectives.
Matching Summary
The successful candidate will provide strategic and technical leadership for the introduction, development, and commercial manufacture of clinical and commercial active pharmaceutical ingredients.
Skills & Requirements
Must-have
15+ years process chemistry experience
API commercial manufacture expertise
cGMP manufacturing operations knowledge
Process equipment and cleaning validation
Deviation management and inspection readiness
Nice-to-have
Strategic thinking and cross-functional leadership
Lean continuous improvement mindset
Innovation in alternative approaches
Executive level communication skills
Key Requirements
Degree (BSc/BEng/Masters/PhD) in Chemistry or Chemical Engineering
Minimum 15 years experience in process chemistry and API commercial manufacture
Proven capability in financial management and budgeting