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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, including selection of dosage form, excipients, and process pathway consistent with target product profile.
Leads development of robust oral formulations and control strategies using QbD principles, including identification of CQAs, CPPs, design space (where appropriate), and lifecycle management plans.
Oversees oral process development and scale-up (e.g., blending, granulation, compression, coating, encapsulation, hot-melt extrusion, spray drying, 3D/continuous manufacturing where applicable), including tech transfer to internal sites and/or CMOs through PPQ and commercialization.
Accountable for CMC deliverables for global submissions (IND/CTA/NDA/MAA variations), ensuring high-quality module content, responses, and inspection readiness for oral drug products.
Establishes platform approaches and standards for oral dosage forms (e.g., enabling formulations, pediatric/geriatric considerations, modified release strategies) to increase reuse and reduce cycle time.
Drives science- and data-based selection and management of CMOs/CDMOs for oral products, including governance, performance, supply risk mitigation, and technical oversight.
Partners effectively with Analytical, Drug Substance, Device (as needed), Regulatory CMC, Quality/GSQ, Supply Chain, and Commercial to assure robust product and process strategies through launch and beyond.
Builds a high-performing global organization; develops talent, ensures appropriate resourcing across programs, and drives a culture of innovation, compliance, and continuous improvement.
Deep expertise in oral solid dose and oral enabling technologies (BCS-driven strategy, solubility/permeability enhancement, amorphous dispersions, salt/co-crystal selection interface, lipid-based formulations where appropriate).
Strong experience in oral pre-formulation and biopharmaceutics-facing formulation design (dissolution, supersaturation, precipitation risk, food effect considerations, IVIVC/biorelevant methods alignment).
Demonstrated capability in oral process development, scale-up, and manufacturing science (unit operations, PAT, continuous manufacturing understanding, process robustness, control strategy).
Experience with global GMP and oral product regulatory expectations, including CMC submission strategy, lifecycle management, and inspection readiness.
Proven leadership in tech transfer to internal sites and CMOs, including process validation/PPQ execution and commercial troubleshooting.
Knowledge of packaging/CCS considerations for oral products (e.g., blister vs bottle, moisture/oxygen/light protection, stability strategy alignment).
Strategic thinking, facilitative leadership.
Executive leadership presence and confidence.
Enterprise level leadership with the ability to inspire, motivate and drive results.
Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing.
Ability to assemble and manage a diverse and high performing team.
Demonstrated ability to lead teams across functions, regions and cultures.
Ability to distill complex issues and ideas down to simple comprehensibility.
Proven skills as leader who can engender credibility and confidence within and outside the company.
Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.
Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 25+ years relevant industry experience.
Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 20+ years relevant industry experience.
PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 15+ years relevant industry experience.
Demonstrated people and program management skills, critical and out-of-the-box thinking ability.
Demonstrated ability to anticipate issues and manage a team to proactively implement solutions.
Experience in assuring the implementation of required quality processes and standards to facilitate smooth transition from product development to commercialization.
Demonstrated expertise in writing regulatory documents.
Understands the structure, functions, and methods of the global Takeda organization and overall Takeda R&D and Commercial operations.
Excellent organizational and communication skills. Has the ability to influence at all levels of the organization and manage projects and initiatives across businesses and the globe.
Demonstrated ability to negotiate difficult issues and arrive at mutually beneficial solutions.
Ability to analyze a wide variety of information and data to make management decisions regarding potential risks associated with product quality and regulatory compliance.
Demonstrated ability to effectively lead and motivate a team of direct reports, build on strengths, and address areas for improvement.
Proven record of building mutually-respectful relationships across global regions and companies in order to foster communication and achieve strategic goals.
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
Allowances: Commutation, Housing, Overtime Work etc.
Salary Increase: Annually, Bonus Payment: Twice a year
Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45
Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.
Flexible Work Styles: Flextime, Telework
Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.
