API R&D Tech Lead (CIP)
Core
Process chemistry leader defining non-infringing API routes and driving end-to-end process development from feasibility to commercialization.
Role type
Senior IC process chemistry leader (API development)
Builds
Safe, scalable, and cost-effective manufacturing processes for APIs
Domain
Pharmaceutical process chemistry and API manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing processes)
Required skills
Process Development, Green Chemistry, Feasibility Studies, Scale-Up Process Management, Technology Transfer, Data Analysis, Project Management, Intellectual Property Strategy, Quality By Design (QbD), Regulatory Compliance
Preferred skills
Advanced patent mining, Lab-to-plant reproducibility, Impurity synthesis, Polymorph selection, API-formulation interface
Technologies
None explicitly stated
Responsibilities
Define non-infringing route selection strategies, drive feasibility and optimization of synthetic routes, plan and execute experiments using QbD principles, lead cross-functional coordination and phase gate reviews, support tech transfer and troubleshoot scale-up issues, ensure regulatory compliance and DMF documentation, define specifications and control strategies, mentor teams and drive innovation
Seniority
Senior, hands-on IC with mentorship responsibilities
