Process Engineer Molecules API Process Science; Associate Director

Process Engineer Small Molecules API Process Science (Associate Director)

TAKEDA PHARMACEUTICALS AMERICA, INC. is seeking an Associate Director to provide process engineering support in batch or continuous API platforms, integrating mechanistic modeling, process simulation, and analysis to enhance process understanding and controls.

Job : R0162704 Date posted: 09/15/2025

Cambridge, MA (Hybrid)

As a Process Engineer Small Molecules API Process Science (Associate Director), you will provide process engineering support in batch or continuous API platforms from clinical to commercial stage. You will integrate mechanistic modelling, process simulation, and analysis into current and future processes as part of product Life‑Cycle Management to enhance process understanding and controls. You will identify and implement continuous improvement opportunities related to equipment and processes as a core member of a cross‑functional process team and provide support to marketing applications for global markets, as well as play a key role in responding to Requests for Qualification (RfQs) from global health authorities.

• Lead the Global Process Science, Small Molecules API Manufacturing Science team and serve as Takeda’s expert on small molecule API process and technologies.
• Provide strong leadership for activities including API Manufacturing Process Characterization, Technology Transfer from/to external CMOs and/or internal manufacturing sites, Process validation, Risk assessment, Global expansion, COGS management, Regulatory Activities, and Process/Product knowledge.
• Lead projects within Takeda product portfolio, both development and commercial, to support Small Molecules API Manufacturing Sciences activities.
• Develop and implement strategies for continuous improvement on the manufacturing of marketed products in the late phase of the product life cycle.
• Lead the team to implement the manufacturing strategy for key Takeda products at the internal manufacturing network and external CMOs.
• Lead the effort to create systems and procedures for best practice in commercial technology transfer and process validation.
• Serve as the central hub of manufacturing process knowledge, ensuring expertise and process knowledge are shared across global Takeda products and sites.
• Collaborate effectively with functions such as API in Oncology & External Supply Small Molecules Unit, Network strategy in Strategy & Business Excellence, Manufacturing Operating Unit Site leads, Local Technical Services functions, Pharmaceutical Sciences counterparts, Global Quality, Regulatory CMC, and other key functional groups.

• Provide vision and strategy for manufacturing technology projects.
• Lead and influence the local Manufacturing Science organization toward global manufacturing strategy alignment.
• Communicate Global Manufacturing Sciences visions across functions.
• Understand API manufacturing from phase‑appropriate development stage to commercial scale.
• Possess a sound understanding of Organic Chemistry/Pharmaceutical chemistry.
• Work effectively within a multi‑functional team (Engineering, Manufacturing Operations, Manufacturing Sciences, CMC team, etc.).
• Utilize root cause analysis techniques to investigate process and equipment issues and deliver robust corrective and preventative actions.
• Provide SME support for due diligence of M&A and other in‑licensing activities.
• Lead or support tech transfer of new processes and unit operations across batch and continuous platforms.

• MS/PhD in Chemical or Process Engineering or Pharmaceutical Engineering.
• At least 5+ years’ experience in a cGMP environment.
• At least 5+ years of pharmaceutical industry experience in small molecules (preferred).
• Self‑motivated, strong interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.
• Strategic enterprise thinking, finding innovative ways to serve patients and build reputation and trust.
• Create an environment that inspires and enables people.
• Focus on priority areas to deliver superior results.
• Elevate capabilities for now and the future.