Process Engineer Molecules API Process Science; Associate Director

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Title:

Process Engineer Small Molecules API Process Science (Associate Director)

Location:

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 through application of chemical engineering and process chemistry fundamentals from clinical to commercial stage. You will also 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 RtQs 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 the following activities, along with Pharmaceutical Sciences and/or Operation Units: 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, Process / Product knowledge.
• Lead projects within Takeda product portfolio, both development and commercial, to support Small Molecules API Manufacturing Sciences activities.
• Develop and implements strategies for the 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 internal manufacturing network and external CMOs.
• Lead the effort to create systems and procedures for best practice in commercial technology transfer, process validation.
• Lead the team that serves as the central hub of manufacturing process knowledge and establishes system and procedures to ensure the expertise and process knowledge are shared across global Takeda products and sites.
• Accountable for successful collaboration with
• Other functions such as API in Oncology & External Supply Small Molecules Unit, Network strategy in Strategy & Business Excellence etc.
• Manufacturing Operating Unit Site leads.
• Local Technical Services functions.
• Pharmaceutical Sciences counterparts.
• Other key functional groups such as Global Quality, Regulatory CMC etc.

• Provide vision and strategy for manufacturing technology projects
• Ability to lead and influence the local Manufacturing Science organization for global manufacturing strategy alignment.
• Effectively communicate Global Manufacturing Sciences visions across the functions.
• Understanding of API manufacturing from phase appropriate development stage to commercial scale.
• Must have sound understanding of Organic Chemistry/Pharmaceutical chemistry.
• Ability to work within a multi‑functional team (i.e., Engineering, Manufacturing Operations, Manufacturing Sciences, CMC team etc.).
• Utilize root cause analysis techniques to investigate process and equipment issues and deliver robust and sustainable corrective and preventative actions in a cross‑functional team.
• Provide SME support for Due Diligence of M&A and other in‑licensing activities.
• Lead/support the tech transfer of new processes and unit operations across batch and continuous processing 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 is preferred.
• Must be self‑motivated, have good…