Head of Oral Drug Products (Vice President)
Takeda
13 hours ago
Remote friendly (Boston, MA)
United States
$259,000 - $407,000 USD yearly
Operations
OBJECTIVES/PURPOSE
- Leads the global Oral Drug Product organization and delivery of oral drug product development from early phase through commercialization and lifecycle management.
- Sets strategy and builds capabilities for robust, scalable oral formulations and manufacturing processes, including tech transfer and process validation/PPQ readiness.
- Partners with PharmSci functions and key stakeholders (GSQ, Quality, Regulatory CMC, Commercial, R&D, Supply Chain) and external partners to deliver high-quality oral products.
ACCOUNTABILITIES
- Owns the global Oral Drug Product strategy and operating model to deliver phase-appropriate, scalable, and robust oral dosage forms across the pipeline and lifecycle.
- Accountable for oral drug product design and development from pre-formulation through clinical and commercial readiness (dosage form, excipients, and process pathway).
- Leads development of robust oral formulations and control strategies using QbD (CQAs, CPPs, design space where appropriate, lifecycle management plans).
- Oversees oral process development and scale-up (blending, granulation, compression, coating, encapsulation, hot-melt extrusion, spray drying, 3D/continuous manufacturing where applicable), including tech transfer through PPQ and commercialization.
- Accountable for CMC deliverables for global submissions (IND/CTA/NDA/MAA variations), ensuring module content, responses, and inspection readiness.
- Establishes platform approaches and standards for oral dosage forms to increase reuse and reduce cycle time.
- Drives selection and management of CMOs/CDMOs (governance, performance, supply risk mitigation, technical oversight).
- Partners with Analytical, Drug Substance, Device (as needed), Regulatory CMC, Quality/GSQ, Supply Chain, and Commercial through launch and beyond.
- Builds a high-performing global organization (talent, resourcing, innovation, compliance, continuous improvement).
TECHNICAL/FUNCTIONAL & REQUIRED SKILLS
- Deep expertise in oral solid dose and enabling technologies (BCS-driven strategy, solubility/permeability enhancement, amorphous dispersions, salt/co-crystal interfaces, lipid-based formulations where appropriate).
- Strong oral pre-formulation and biopharmaceutics-facing formulation design (dissolution, supersaturation/precipitation risk, food effect, IVIVC/biorelevant methods alignment).
- Demonstrated oral process development, scale-up, and manufacturing science (unit operations, PAT, continuous manufacturing understanding, process robustness, control strategy).
- Experience with global GMP and oral regulatory expectations (CMC strategy, lifecycle management, inspection readiness).
- Proven tech transfer leadership (process validation/PPQ execution; commercial troubleshooting).
- Knowledge of packaging/CCS considerations (blister vs bottle; moisture/oxygen/light protection; stability strategy alignment).
LEADERSHIP SKILLS
- Strategic thinking and facilitative leadership; executive presence.
- Excellent written/verbal communication and ability to lead diverse cross-functional teams across regions.
- Ability to distill complex issues and build credibility with internal/external partners.
- Strong decision-making, stakeholder input, and transparent execution.
QUALIFICATIONS
- Bachelor’s degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science with 25+ years relevant industry experience; or
- Master’s degree with 20+ years relevant industry experience; or
- PhD with 15+ years relevant industry experience.
- Demonstrated people/program management; critical thinking; proactive issue anticipation.
- Experience ensuring quality processes for smooth transition from development to commercialization.
- Demonstrated expertise writing regulatory documents.
EDUCATION/PREFERRED
- PhD/Master’s/Bachelor’s in relevant fields as specified above.
BENEFITS
- Not included.
APPLICATION INSTRUCTIONS
- Not included beyond the application acknowledgement text provided in the input.
- Leads the global Oral Drug Product organization and delivery of oral drug product development from early phase through commercialization and lifecycle management.
- Sets strategy and builds capabilities for robust, scalable oral formulations and manufacturing processes, including tech transfer and process validation/PPQ readiness.
- Partners with PharmSci functions and key stakeholders (GSQ, Quality, Regulatory CMC, Commercial, R&D, Supply Chain) and external partners to deliver high-quality oral products.
ACCOUNTABILITIES
- Owns the global Oral Drug Product strategy and operating model to deliver phase-appropriate, scalable, and robust oral dosage forms across the pipeline and lifecycle.
- Accountable for oral drug product design and development from pre-formulation through clinical and commercial readiness (dosage form, excipients, and process pathway).
- Leads development of robust oral formulations and control strategies using QbD (CQAs, CPPs, design space where appropriate, lifecycle management plans).
- Oversees oral process development and scale-up (blending, granulation, compression, coating, encapsulation, hot-melt extrusion, spray drying, 3D/continuous manufacturing where applicable), including tech transfer through PPQ and commercialization.
- Accountable for CMC deliverables for global submissions (IND/CTA/NDA/MAA variations), ensuring module content, responses, and inspection readiness.
- Establishes platform approaches and standards for oral dosage forms to increase reuse and reduce cycle time.
- Drives selection and management of CMOs/CDMOs (governance, performance, supply risk mitigation, technical oversight).
- Partners with Analytical, Drug Substance, Device (as needed), Regulatory CMC, Quality/GSQ, Supply Chain, and Commercial through launch and beyond.
- Builds a high-performing global organization (talent, resourcing, innovation, compliance, continuous improvement).
TECHNICAL/FUNCTIONAL & REQUIRED SKILLS
- Deep expertise in oral solid dose and enabling technologies (BCS-driven strategy, solubility/permeability enhancement, amorphous dispersions, salt/co-crystal interfaces, lipid-based formulations where appropriate).
- Strong oral pre-formulation and biopharmaceutics-facing formulation design (dissolution, supersaturation/precipitation risk, food effect, IVIVC/biorelevant methods alignment).
- Demonstrated oral process development, scale-up, and manufacturing science (unit operations, PAT, continuous manufacturing understanding, process robustness, control strategy).
- Experience with global GMP and oral regulatory expectations (CMC strategy, lifecycle management, inspection readiness).
- Proven tech transfer leadership (process validation/PPQ execution; commercial troubleshooting).
- Knowledge of packaging/CCS considerations (blister vs bottle; moisture/oxygen/light protection; stability strategy alignment).
LEADERSHIP SKILLS
- Strategic thinking and facilitative leadership; executive presence.
- Excellent written/verbal communication and ability to lead diverse cross-functional teams across regions.
- Ability to distill complex issues and build credibility with internal/external partners.
- Strong decision-making, stakeholder input, and transparent execution.
QUALIFICATIONS
- Bachelor’s degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science with 25+ years relevant industry experience; or
- Master’s degree with 20+ years relevant industry experience; or
- PhD with 15+ years relevant industry experience.
- Demonstrated people/program management; critical thinking; proactive issue anticipation.
- Experience ensuring quality processes for smooth transition from development to commercialization.
- Demonstrated expertise writing regulatory documents.
EDUCATION/PREFERRED
- PhD/Master’s/Bachelor’s in relevant fields as specified above.
BENEFITS
- Not included.
APPLICATION INSTRUCTIONS
- Not included beyond the application acknowledgement text provided in the input.