Senior SME - Drug Product (Small Molecule)
Core
Senior SME leading technical transfers, product control strategies, and regulatory readiness for small molecule drug products with external manufacturing partners.
Role type
Senior IC pharmaceutical manufacturing SME (small molecule)
Builds
Commercial supply of small molecule drug products via external CMOs
Domain
Biopharma / Small molecule drug product manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Technology transfer to external CMOs, GMP compliance, process validation, continued process verification, risk assessment, root cause analysis, regulatory filing support, supplier management
Preferred skills
Oral solid dose manufacturing scale-up, Quality by Design, statistical process control, lifecycle management tools, leading complex technical investigations
Technologies
GxP Regulations, Lean Management
Responsibilities
Lead technology transfers to contract manufacturing organizations, define and maintain product control strategies, manage process validation and change management, lead cross-functional investigations for deviations, provide technical input for regulatory filings
Seniority
Senior, hands-on IC
