Associate Scientific Director, Synthetic Molecule DS Project Lead

Takeda•Cambridge, MA

12d•Hybrid

About The Position

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.

Requirements

Bachelors degree and 15+ years relevant industry experience
Masters 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 leadership capacity with full accountability for synthetic molecule Chemistry and/or Engineering deliverables (e.g., Chemistry Lead, Engineering Lead, Drug Substance Lead)
Experience managing work executed by internal development teams, including defining and prioritizing work packages, translating overall program objectives into clear deliverables, driving accountability through matrix leadership, and leading issue resolution to ensure high-quality execution.
Experience managing work executed by external partners (e.g., CDMOs), including partner selection/qualification, governance and oversight, tech transfer support and work package execution, issue resolution/escalation, and vendor performance management.
Experience partnering with manufacturing organizations (internal GMP facilities and/or external CDMOs) to plan and execute manufacturing campaigns in compliance with cGMP, with leadership of late-stage PPQ/validation readiness activities preferred.
Working knowledge of current Good Manufacturing Practices (cGMP) applicable to synthetic molecule drug substance manufacturing.
Proven ability to work effectively in a multi-disciplinary, matrixed team environment.
Experience contributing to CMC regulatory submissions (e.g., IND/CTA, NDA/MAA) and/or supporting responses to Health Authority questions (late-stage filing experience preferred)
Structured analytical and problem-solving capability, able to troubleshoot complex technical and program issues, determine root cause, and drive risk-based resolution across stakeholders.
Proven ability to lead through matrix influence on global, cross-functional teams, building alignment across technical, quality, operations, and governance stakeholders without formal authority.
Strong verbal and written communication skills, including clear documentation of issues, decisions, risks, and mitigation plans; technical writing skills to support internal technical documents and CMC content.
Fluency in English (written and spoken) sufficient to perform the essential functions of the role in a global business environment.
Strong working knowledge of synthetic small molecule DS process development and late-stage manufacturing interfaces (internal and external).
Working knowledge of process characterization and process validation principles, including phase-appropriate deliverables, validation readiness expectations, and execution planning.
Demonstrated ability to apply Quality by Design (QbD) principles across DS/PV deliverables, including practical risk assessment, control strategy concepts, and knowledge management discipline.
Risk and issue management capability: proactively identifies and communicates risk posture, develops mitigation plans with owners/timelines, drives follow-through, and escalates with options and recommendations as needed.
Governance and decision-framing skills: prepares governance-ready narratives and materials; frames trade-offs and recommendations to enable timely leadership decisions.
Quality mindset and GMP documentation discipline, with working knowledge of applicable SOPs and operating model requirements and a focus on inspection readiness.
Digital fluency and independent, responsible use of approved generative AI tools: Demonstrated ability to leverage digital tools to improve cross-functional execution, transparency, and decision readiness; uses approved generative AI tools to accelerate preparation of governance-ready materials independently and responsibly, ensuring human review, traceability, and protection of confidential information, and may coach peers on effective use within applicable policies
Facilitation, coordination, and project management discipline (planning, tracking, dependency management, action/decision documentation) to deliver predictable execution across multiple workstreams.
External partner governance capability, including effective collaboration with CDMOs/vendors, clear technical communication, issue escalation, and vendor performance management.
Strong organization and prioritization skills, balancing timelines, scope, and resource constraints while ensuring disciplined fiscal stewardship.
Capability building and continuous improvement mindset, including mentoring/coaching junior DSL/PVLs, participating in Community of Practice activities, and contributing to standards/templates/job aids.

Nice To Haves

experience in pivotal process design, criticality assessment, and establishment of process design space/control strategy
leadership of late-stage PPQ/validation readiness activities
late-stage filing experience

Responsibilities

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 escalate 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.