Associate Scientific Director, Synthetic Molecule DS Project Lead

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Objective/Purpose

In Pharmaceutical Sciences, Synthetic Molecule Process Development (SMPD) we develop and leverage the scientific expertise of our diverse talent to ensure patient safety and access to medicines through the design, development, and understanding of robust, sustainable, low-cost manufacturing processes, while ensuring on-time delivery of high-quality synthetic molecule drug substance.

SMPD is searching for an Associate Scientific Director, Synthetic Molecule DS Project Lead in our Drug Substance Portfolio Leadership (DSPL) group. This experienced leader provides cross-functional Drug Substance (DS) and/or Process Validation (PV) leadership for late-stage synthetic molecule programs, ensuring phase-appropriate strategy and consistent, high-quality execution aligned to SMPD standards and the SMPD DS operating model. The incumbent serves as a senior matrix leader on Pharm Sci teams, driving risk-based decision-making, governance-ready recommendations, stakeholder alignment, and disciplined fiscal stewardship.

The role develops and mentors DSL/PVL talent, strengthens the DSL Community of Practice (CoP), and promotes harmonized expectations and best practices across regions and sub-functions.

The incumbent anticipates strategic inflection points, frames trade-offs and options for leadership decision-making, and contributes to continuous improvement of the DS operating model (e.g., SOPs, job aids, templates, and leadership playbooks). The role may represent DSPL/SMPD in cross-functional forums and program reviews, may lead PV execution on complex assets, and may support due diligence and pipeline assessments to accelerate integration and execution.

Accountabilities:

• Provide cross-functional Drug Substance Leadership (DSL) for late-stage synthetic molecule programs, ensuring phase-appropriate DS strategy and consistent, high-quality execution aligned to global standards and the SMPD DS operating model; drive cross-functional alignment and governance-ready decision making.
• Provide Process Validation Leadership (PVL) beginning at Process Characterization Assessment (PCA), driving validation strategy, readiness, and execution through late-stage deliverables in alignment with governance, quality, and inspection readiness expectations.
• Integrate program resources (e.g., budget, timelines, priorities) and the broader program context to prioritize, allocate, and sequence SMPD DS working-team activities in a phase-appropriate, risk-aligned manner; frame trade-offs and ensure disciplined fiscal stewardship.
• Ensure application of Quality by Design (QbD) principles across DS/PV deliverables (e.g., criticality assessment, control strategy concepts, risk assessments, and knowledge management) for the programs supported.
• Own program-level DS/PV risk posture: proactively identify, document, and communicate risks/issues; develop mitigation plans with owners and timelines; drive follow-through; and escalations with options and recommendations to appropriate stakeholders and DSPL/SMPD leadership.
• Develop organizational capability through mentoring/coaching junior DSL/PVLs (e.g., onboarding, peer review of key deliverables, and sharing best practices), strengthening the DSL Community of Practice (CoP) and community standards.
• May lead and/or contribute to cross-functional initiatives that improve the synthetic molecule DS operating model and SMPD ways of working (e.g., SOPs, job aids, templates, leadership playbooks), reinforcing consistent expectations across regions and sub-functions.
• May support due diligence and late-stage pipeline assessments by leading/partnering on technical evaluations, DS/PV risk posture assessment, and integration recommendations to accelerate execution and reduce delivery risk.
• May represent Takeda in cross-industry consortia and external forums (e.g., IQ Consortium, JPMA Quality & Technology Committee, AMED Regulatory Science Research Group), contributing SME perspective, sharing best practices, and translating external insights into internal standards and improvements for DS/PV strategy, governance, and ways of working.

Education & Competencies (Technical and Behavioral):

Required:

• Bachelor's degree and 15+ years relevant industry experience
• Master's degree; 13+ years relevant industry experience
• PhD; 7+ years relevant industry experience
• Demonstrated experience in synthetic small molecule drug substance (DS) process development; experience in pivotal process design, criticality assessment, and establishment of process design space/control strategy preferred.
• Demonstrated experience supporting late-stage, cross-functional development teams in a…