Global Manufacturing Sciences Process Science Lead – Molecules API; Sr. Manager

Global Manufacturing Sciences Process Science Lead – Small Molecules API (Sr. Manager)

Senior individual contributor role in Global Manufacturing Science (GMSci) serving as the subject matter expert and primary technical contact for Takeda’s small molecule API manufacturing for synthetic drug substance across the product lifecycle.

• Lead and support process design, scale‑up, technology transfer, and ongoing commercial manufacturing for small‑molecule drug substance, including ADCs.
• Act as SME to troubleshoot complex manufacturing issues, including deviations and investigations; drive timely problem solving and technical decision‑making.
• Use appropriate tools, including statistical analysis, to interpret manufacturing data and identify root causes for continuous improvement.
• Manage drug substance manufacturing activities for assigned programs, coordinating external partners (CROs/CMOs).
• Drive strong technical execution with contract manufacturers, ensuring successful tech transfers and effective collaboration during troubleshooting and optimization.
• Author and review key CMC and quality deliverables such as protocols, validation reports, methods, technology transfer reports, investigation reports, and technical reports supporting submissions.
• Provide regulatory CMC support by authoring/reviewing drug substance (and relevant drug product) CMC sections for global submissions (IND/NDA/MAA and annual reports) and supporting responses to health authority questions and changes.
• Ensure documentation and execution meet internal procedures and regulatory expectations, and participate in audit/inspection preparation and coordination.
• Maintain strong adherence to quality systems (SOP training, deviations/investigations, CAPAs, change controls) and support continuous improvement of departmental processes.
• Apply lifecycle thinking, including QbD principles, to development and commercial programs.
• Contribute to sustainability improvements in drug substance manufacturing in alignment with Takeda’s corporate Planet goals.
• Communicate complex technical topics clearly and concisely to both technical and non‑technical stakeholders; prepare targeted updates and presentations for management as needed.
• Coach and mentor colleagues when appropriate, supporting capability building in problem‑solving and technical excellence.

• Advanced degree (MSc or PhD) in Chemistry, Chemical Engineering, Pharmacy, or a closely related field.
• At least 5 years of relevant experience in the pharmaceutical industry.
• Direct experience in pilot plant manufacturing of synthetic drug substance (API); ADC knowledge and manufacturing experience is an advantage.
• Strong understanding of ICH and global regulatory guidelines applicable to drug substance manufacturing and control.
• Experience with phase‑appropriate development and clinical supply processes.
• Demonstrated experience authoring CMC sections for regulatory submissions (e.g., IND/IMPD/NDA/MAA).
• Proven SME‑level experience working within quality systems (deviations/investigations, CAPAs, change controls, etc.).
• Experience using statistical tools for data evaluation and decision‑making.
• Knowledge of EU and US CMC requirements and familiarity with inspection expectations (MHRA/FDA) is beneficial.
• Ability to travel up to 20%, domestic & international.

U.S. Base Salary Range: $ – $. U.S. based employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, volunteer time off, company holidays, sick time (up to 80 hours), and paid vacation (up to 120 hours).

Boston, MA

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.