Director, Technical Operations (Small Molecule Drug Product)
Core
Lead technical operations for small molecule drug product manufacturing, ensuring GMP compliance, operational excellence, and successful technology transfer from R&D to commercial production.
Role type
Director, Technical Operations (Small Molecule Drug Product)
Builds
Commercial supply of small molecule medicines
Domain
Biopharmaceuticals / Small Molecule Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing operations)
Required skills
Small molecule drug product manufacturing, Process engineering, Scale-up, Validation, Troubleshooting, Technology transfer, Lifecycle management, GMP compliance, Root cause analysis, CAPA management, Risk mitigation, Workforce planning, Digital/analytics integration
Preferred skills
Advanced degree in Chemistry/Chemical Engineering, Organizational transformation, Cross-functional alignment, Strategic resource allocation
Technologies
Process data platforms, CPV analytics, Advanced modeling
Responsibilities
Own site-level product introductions and technology transfer strategy; Lead technical risk reviews and implement mitigations; Build a culture of safety and scientific rigor; Champion business process improvement and digital integration; Drive portfolio prioritization and resource allocation; Act as escalation point for complex multi-site technical issues
Seniority
Director, strategic leadership & hands-on technical expertise
