Associate Scientific Director, Synthetic Molecule DS Project Lead
Takeda
August 22, 2026
Remote friendly (Cambridge, MA)
United States
$154,400 - $242,550 USD yearly
Clinical Research and Development
Objective/Purpose
- Provide cross-functional Drug Substance (DS) and/or Process Validation (PV) leadership for late-stage synthetic molecule programs to ensure phase-appropriate strategy and high-quality execution aligned to SMPD standards.
Accountabilities
- Provide DS leadership; drive cross-functional alignment and governance-ready decision making.
- Provide PV leadership beginning at Process Characterization Assessment (PCA) through late-stage deliverables.
- Prioritize, allocate, and sequence DS working-team activities; ensure disciplined fiscal stewardship.
- Apply Quality by Design (QbD) principles across DS/PV deliverables.
- Own and manage DS/PV risks/issues; develop mitigations; escalate with options/recommendations.
- Mentor/coaching junior DSL/PVLs; strengthen DSL Community of Practice (CoP).
- Lead and/or contribute to initiatives improving the DS operating model and ways of working (e.g., SOPs, templates).
- Support due diligence and pipeline assessments; represent DSPL/SMPD in external forums.
Required Qualifications
- BS with 15+ years industry experience; or MS with 13+; or PhD with 7+.
- Demonstrated synthetic small molecule DS process development experience (pivotal design, criticality assessment, process design space/control strategy preferred).
- Leadership experience with full accountability for Chemistry and/or Engineering deliverables.
- Experience managing internal teams and external partners (e.g., CDMOs), including tech transfer and governance.
- Working knowledge of cGMP for synthetic molecule DS manufacturing.
- Experience with CMC regulatory submissions (IND/CTA, NDA/MAA) and/or responses to Health Authority questions.
Preferred/Skills
- Strong matrix leadership, communication, governance/decision framing, risk/issue management, QbD application, GMP documentation discipline, digital fluency (approved generative AI use with human review/traceability), and project management.
Location/Work setup
- Cambridge, MA (Hybrid).
Compensation & Benefits (if provided)
- U.S. base salary range: $154,400.00–$242,550.00; eligible for incentives and benefits (medical/dental/vision, 401(k), disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time, paid vacation).
Application instructions
- Apply via the “Apply” button (employment application process begins; information processed per Privacy Notice and Terms of Use).
- Provide cross-functional Drug Substance (DS) and/or Process Validation (PV) leadership for late-stage synthetic molecule programs to ensure phase-appropriate strategy and high-quality execution aligned to SMPD standards.
Accountabilities
- Provide DS leadership; drive cross-functional alignment and governance-ready decision making.
- Provide PV leadership beginning at Process Characterization Assessment (PCA) through late-stage deliverables.
- Prioritize, allocate, and sequence DS working-team activities; ensure disciplined fiscal stewardship.
- Apply Quality by Design (QbD) principles across DS/PV deliverables.
- Own and manage DS/PV risks/issues; develop mitigations; escalate with options/recommendations.
- Mentor/coaching junior DSL/PVLs; strengthen DSL Community of Practice (CoP).
- Lead and/or contribute to initiatives improving the DS operating model and ways of working (e.g., SOPs, templates).
- Support due diligence and pipeline assessments; represent DSPL/SMPD in external forums.
Required Qualifications
- BS with 15+ years industry experience; or MS with 13+; or PhD with 7+.
- Demonstrated synthetic small molecule DS process development experience (pivotal design, criticality assessment, process design space/control strategy preferred).
- Leadership experience with full accountability for Chemistry and/or Engineering deliverables.
- Experience managing internal teams and external partners (e.g., CDMOs), including tech transfer and governance.
- Working knowledge of cGMP for synthetic molecule DS manufacturing.
- Experience with CMC regulatory submissions (IND/CTA, NDA/MAA) and/or responses to Health Authority questions.
Preferred/Skills
- Strong matrix leadership, communication, governance/decision framing, risk/issue management, QbD application, GMP documentation discipline, digital fluency (approved generative AI use with human review/traceability), and project management.
Location/Work setup
- Cambridge, MA (Hybrid).
Compensation & Benefits (if provided)
- U.S. base salary range: $154,400.00–$242,550.00; eligible for incentives and benefits (medical/dental/vision, 401(k), disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time, paid vacation).
Application instructions
- Apply via the “Apply” button (employment application process begins; information processed per Privacy Notice and Terms of Use).