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 thescientific expertiseof ourdiverse talent to ensure patientsafety and access to medicines through the design development and understandingof robustsustainable low-cost manufacturing processes while ensuring on-timedelivery 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 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.

Education & Competencies (Technical and Behavioral):

Required:

• 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 teamsin a leadership capacity with full accountability forsynthetic 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 campaignsin 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)

Knowledge and Skills:

• 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; usesapproved generative AI toolsto 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.

Location: Cambridge MA (Hybrid)

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical dental vision insurance a 401(k) plan and company match short-term and long-term disability coverage basic life insurance a tuition reimbursement program paid volunteer time off company holidays and well-being benefits among others. U.S. based employees are also eligible to receive per calendar year up to 80 hours of sick time and new hires are eligible to accrue up to 120 hours of paid vacation.

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