Head of Oral Drug Products (Vice President)
Takeda
August 24, 2026
Remote friendly (Boston, MA)
United States
$259,000 - $407,000 USD yearly
Operations
Objectives/Purpose
- Lead global Oral Drug Product organization and oral drug product development from early phase through commercialization and lifecycle management.
- Set strategy and build capabilities for robust, scalable oral formulations and manufacturing processes (tech transfer; process validation/PPQ readiness).
- Partner with PharmSci functions and stakeholders (GSQ, Quality, Regulatory CMC, Commercial, R&D, Supply Chain) and external partners to deliver high-quality oral products.
Accountabilities
- Own global oral drug product strategy and operating model across pipeline and lifecycle.
- Lead oral drug product design/development (pre-formulation through clinical/commercial readiness), including dosage form/excipient/process pathway selection aligned to target product profile.
- Develop formulations and control strategies using QbD (CQAs/CPPs/design space where appropriate; lifecycle plans).
- Oversee process development and scale-up (e.g., blending, granulation, compression, coating, encapsulation, hot-melt extrusion, spray drying, 3D/continuous manufacturing where applicable) and tech transfer through PPQ/commercialization.
- Ensure CMC deliverables for global submissions (IND/CTA/NDA/MAA variations), including module quality and inspection readiness.
- Establish oral platform approaches/standards and lead CMO/CDMO governance and technical oversight.
- Build a high-performing global organization and drive innovation, compliance, and continuous improvement.
Qualifications/Skills
- BS in relevant field + 25+ years; MS + 20+ years; or PhD + 15+ years.
- Deep expertise in oral solid dose/enabling technologies, pre-formulation/biopharmaceutics, oral process development/manufacturing science.
- Experience with GMP and oral regulatory/CMC expectations; tech transfer and process validation/PPQ.
- Strong leadership, communication, collaboration, and complex decision-making.
Benefits (explicit)
- Hybrid work; location Boston, MA; U.S. base salary range $259,000–$407,000.
- Potential eligibility for incentives and benefits including medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid time off, sick time, and holidays.
Application
- Apply via the “Apply” button (employment application process begins upon submission).
- Lead global Oral Drug Product organization and oral drug product development from early phase through commercialization and lifecycle management.
- Set strategy and build capabilities for robust, scalable oral formulations and manufacturing processes (tech transfer; process validation/PPQ readiness).
- Partner with PharmSci functions and stakeholders (GSQ, Quality, Regulatory CMC, Commercial, R&D, Supply Chain) and external partners to deliver high-quality oral products.
Accountabilities
- Own global oral drug product strategy and operating model across pipeline and lifecycle.
- Lead oral drug product design/development (pre-formulation through clinical/commercial readiness), including dosage form/excipient/process pathway selection aligned to target product profile.
- Develop formulations and control strategies using QbD (CQAs/CPPs/design space where appropriate; lifecycle plans).
- Oversee process development and scale-up (e.g., blending, granulation, compression, coating, encapsulation, hot-melt extrusion, spray drying, 3D/continuous manufacturing where applicable) and tech transfer through PPQ/commercialization.
- Ensure CMC deliverables for global submissions (IND/CTA/NDA/MAA variations), including module quality and inspection readiness.
- Establish oral platform approaches/standards and lead CMO/CDMO governance and technical oversight.
- Build a high-performing global organization and drive innovation, compliance, and continuous improvement.
Qualifications/Skills
- BS in relevant field + 25+ years; MS + 20+ years; or PhD + 15+ years.
- Deep expertise in oral solid dose/enabling technologies, pre-formulation/biopharmaceutics, oral process development/manufacturing science.
- Experience with GMP and oral regulatory/CMC expectations; tech transfer and process validation/PPQ.
- Strong leadership, communication, collaboration, and complex decision-making.
Benefits (explicit)
- Hybrid work; location Boston, MA; U.S. base salary range $259,000–$407,000.
- Potential eligibility for incentives and benefits including medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid time off, sick time, and holidays.
Application
- Apply via the “Apply” button (employment application process begins upon submission).