Senior Scientist, Engineering
Core
Lead pharmaceutical process and technology development for small molecule solid dosage drug products from Phase IIb through commercial launch.
Role type
Senior IC process development engineer (pharmaceutical manufacturing)
Builds
New medicines for patients worldwide via internal sites in Ireland/Singapore and global contract manufacturers
Domain
Pharmaceutical industry, small molecule solid dosage, process development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process scale-up, Technology transfer, Design of Experiments (DOE), cGMP compliance, Process validation, Analytical testing, Technical writing, Cross-functional collaboration, Risk-based development, Process modeling
Preferred skills
CMC section authoring, Statistical process control, Big data analytics, Process model validation, Supply chain support, Commercial site interaction
Technologies
Chromatographic techniques, Process modeling tools, Statistical analysis software
Responsibilities
Plan and interpret process development studies (scale-up, tech transfer, validation), Lead drug product working groups, Author technical documents and regulatory filings, Evaluate new technologies and equipment, Perform physical testing and data analysis, Contribute to scientific publications
Seniority
Senior, hands-on IC
