Related skills
quality assurance drug product cmo ppq oral solid dose📋 Description
- Own end-to-end DP OSD tech enablement across external CMOs.
- Deliver formulation, process transfer, scale-up, and PPQ readiness.
- Lead dual-sourcing plan for alternate OSD DP sites and sources.
- Own DP tech transfer, scale-up, PPQ, CPV for OSD processes.
- Define and implement the commercial DP control strategy and CPV plan.
- Drive process robustness and investigations at CMOs (deviations, OOS, OOT).
🎯 Requirements
- MSc/PhD in Pharmaceutical Sciences, Chemical Engineering, Materials Science, or related.
- 15+ years in small-molecule OSD DP from late-stage to commercial with CMOs.
- Leadership of DP tech transfer, scale-up, PPQ, CPV, and DP control strategy.
- Early-career on-plant OSD manufacturing exposure (granulation, compression, coating).
- Strong GMP and ICH Q8-Q12 knowledge applied to DP lifecycle management.
- Investigations and RCA leadership for deviations and CAPAs.
Meet JobCopilot: Your Personal AI Job Hunter
Automatically Apply to Engineering Jobs. Just set your
preferences and Job Copilot will do the rest — finding, filtering, and applying while you focus on what matters.
Help us maintain the quality of jobs posted on Empllo!
Is this position not a remote job?
Let us know!