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

Role Summary

Global Manufacturing Science (GMSci) lead for small molecule API manufacturing, serving as the subject matter expert and primary technical contact across the product lifecycle. Based in Boston, MA, you will define phase-appropriate, fit-for-purpose manufacturing strategies to support process design, scale-up, technology transfer, and commercial supply, while influencing decisions to strengthen manufacturing robustness and supply continuity. You will collaborate with Regulatory, Quality, Analytical Services, Supply Chain, R&D, and leadership as needed.

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 (e.g., 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; contribute to a culture of inspection readiness, including participation in audit/inspection preparation and coordination.
• Maintain strong adherence to quality systems (e.g., 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/or mentor colleagues when appropriate, supporting capability building across problem-solving and technical excellence.

Qualifications

• 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 (Antibody drug conjugates) knowledge and manufacturing experience is an advantage.
• Strong understanding of ICH and global regulatory guidelines and how they apply 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 is highly desired.
• Beneficial would be knowledge of EU and US CMC requirements and familiarity with inspection expectations (e.g., MHRA/FDA) and compliance practices.

Education

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

Additional Requirements

• Ability to travel up to 20%, domestic and international.