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Associate Director - Drug Product
Posted 1 day 14 hours ago by Next Generation Recruitment
Permanent
Full Time
Other
Dublin, Dublin, Ireland
Job Description
Associate Director - Drug Product Global Pharmaceutical Organisation Ireland - Hybrid
An expanding global pharmaceutical organisation is seeking an experienced Associate Director - Drug Product to provide technical leadership across its external manufacturing network.
This role will support Drug Product manufacturing activities for Oral Solid Dose (OSD) products, partnering closely with Contract Manufacturing Organisations (CMOs) to ensure successful technology transfers, manufacturing scale-up, commercialisation and ongoing process performance.
Key Responsibilities- Provide technical oversight of Drug Product manufacturing activities across CMOs.
- Lead technology transfer, process transfer and scale-up activities.
- Support commercial product launches and lifecycle management.
- Lead manufacturing investigations, troubleshooting and process improvement initiatives.
- Drive Root Cause Analysis (RCA), CAPA and FMEA activities.
- Act as the technical lead for manufacturing issues and external manufacturing partners.
- Present technical recommendations and project updates to senior stakeholders.
- Bachelor's Degree in Engineering, Pharmaceutical Sciences, Chemistry or a related discipline.
- 7-10+ years' experience within pharmaceutical manufacturing, MS&T, process engineering or technical operations.
- Strong Oral Solid Dose (OSD) manufacturing experience, including tableting, encapsulation, coating operations and pharmaceutical manufacturing processes.
- Proven experience leading technology transfer, manufacturing scale-up and commercial product launch activities.
- Experience working with Contract Manufacturing Organisations (CMOs) and global external manufacturing networks.
- Strong troubleshooting, manufacturing investigations, Root Cause Analysis (RCA), CAPA and FMEA experience.
- Experience supporting commercial manufacturing operations within a GMP-regulated environment.
- Excellent technical leadership, stakeholder management and presentation skills, with the ability to influence senior leadership.
- Experience supporting capital investment projects (CapEx) and manufacturing improvement initiatives.
- Experience with fluid bed granulation and processing is highly desirable.
- Experience within stick-pack, sachet or other Oral Solid Dose manufacturing technologies would be advantageous.
Next Generation Recruitment
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