Associate Scientific Director, Synthetic Molecule DS Project Lead
Core
Lead cross-functional Drug Substance (DS) and Process Validation (PV) strategies for late-stage synthetic molecule programs, ensuring high-quality execution, risk management, and inspection readiness.
Role type
Senior IC Associate Scientific Director (Synthetic Molecule DS Project Lead)
Builds
Robust, sustainable, low-cost manufacturing processes for synthetic molecule drug substances
Domain
Pharmaceutical Sciences / Synthetic Small Molecule Drug Substance Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Synthetic small molecule DS process development, late-stage manufacturing interface management, cross-functional matrix leadership, external partner (CDMO) governance, Quality by Design (QbD) principles, risk and issue management, CMC regulatory submission support, process characterization and validation planning, fiscal stewardship, mentoring/coaching
Preferred skills
Pivotal process design, criticality assessment, process design space/control strategy establishment, late-stage PPQ/validation readiness leadership, Health Authority response support
Technologies
cGMP compliance tools, generative AI tools (approved), project management software
Responsibilities
Provide cross-functional Drug Substance Leadership (DSL) for late-stage synthetic molecule programs; Provide Process Validation Leadership (PVL) from Process Characterization Assessment (PCA) through late-stage deliverables; Integrate program resources to prioritize and sequence SMPD DS working-team activities; Ensure application of Quality by Design (QbD) principles across DS/PV deliverables; Own program-level DS/PV risk posture and drive mitigation plans; Develop organizational capability through mentoring/coaching junior DSL/PVLs; Support due diligence and late-stage pipeline assessments; Represent Takeda in cross-industry consortia and external forums
Seniority
Senior, hands-on IC with strategic leadership
