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

Role Summary

Global Manufacturing Sciences Process Science Lead – Small Molecules API (Sr. Manager) is a senior individual contributor role serving as the subject matter expert and primary technical contact for Takeda’s small molecule API manufacturing across the product lifecycle. You will define phase-appropriate, fit-for-purpose manufacturing strategies to support process design, scale-up, technology transfer, and commercial supply, working cross-functionally to provide evidence-based technical recommendations and influence decisions that strengthen manufacturing robustness and supply continuity. You will represent Small Molecule Drug Substance in forums with regulatory, quality, analytical services, supply chain, R&D, and leadership as needed. Location: Boston, MA.

Responsibilities

• Lead and/or support process design, scale-up, technology transfer, and ongoing commercial manufacturing support for small molecule drug substance including Antibody-Drug Conjugates (ADCs).
• Act as SME to troubleshoot complex manufacturing issues, including deviations and investigations; drive effective, timely problem solving and technical decision-making.
• Use appropriate tools (including statistical analysis) to interpret manufacturing data, identify root causes, and enable continuous improvement.
• Manage drug substance manufacturing activities for assigned programs, including coordination of external partners (CROs/CMOs).
• Drive strong technical execution with contract manufacturers, ensuring successful tech transfers and effective collaboration during troubleshooting and optimization.
• Author and/or 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 and supporting responses to health authority questions and changes.
• Ensure documentation and execution meet internal procedures and regulatory expectations; contribute to a culture of inspection readiness, including participation 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 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/or mentor colleagues to support capability building across problem-solving and technical excellence.

Qualifications

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

Skills

• Technical communication: ability to convey complex concepts clearly to technical and non-technical stakeholders.
• Problem-solving: strong troubleshooting and root-cause analysis capabilities.
• Project and external partner management: coordination with CROs/CMOs and cross-functional teams.
• Quality systems and regulatory literacy: experience with deviations, investigations, CAPAs, and change controls.
• Data analysis: proficiency with statistical tools to inform decisions.

Education

• Advanced degree (MSc or PhD) in Chemistry, Chemical Engineering, Pharmacy, or a closely related field.

Additional Requirements

• Travel up to 20% to domestic and international sites.