Associate Director-Process Engineer SM API Process Sci

Role Summary

Associate Director-Process Engineer SM API Process Sci. Location Cambridge, MA (Hybrid).

As an Associate Director-Process Engineer SM API Process Sci, 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 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.

Responsibilities

• Leads the GMSci, Global Process Science, Small Molecules API Manufacturing Science organization; may serve as Takeda‚Äôs expert on small molecule API process and technologies.
• Provides leadership for 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.
• Leads projects within Takeda product portfolio, both development and commercial, to support Small Molecules API Manufacturing Sciences activities.
• Develops and implements strategies for continuous improvement on the manufacturing of Marketed Products in the late phase of the product life cycle.
• Leads the team to implement the manufacturing strategy for key Takeda products at internal manufacturing network and external CMOs.
• Leads efforts to create systems and procedures for best practice in commercial technology transfer, process validation.
• Leads the team that serves as the central hub of manufacturing process knowledge and establishes systems and procedures to ensure the expertise and process knowledge are shared across global Takeda products and sites.
• Accountable for successful collaboration with other functions within GMS such as API in Onco/ES SM OpU, Network strategy in Strategy & Business Excellence, and other key functional groups such as Global Quality, Regulatory CMC.
• Manufacturing Operating Unit Site leads; Local Technical Services functions; Pharmaceutical Sciences counterparts.
• Lead/support the tech transfer of new processes and unit operations across batch and continuous processing platforms.

Leadership

• Provide vision and strategy for manufacturing technology projects.
• Ability to lead and influence the local MSci organization for global manufacturing strategy alignment.
• Effectively communicate Global Manufacturing Sciences visions across the functions.
• Understand API manufacturing from phase-appropriate development stage to commercial scale; strong foundation in Organic/Pharmaceutical chemistry.
• Work within a multi-functional team (Engineering, Manufacturing Operations, Manufacturing Sciences, CMC, etc.).
• Utilize root cause analysis 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/support the tech transfer of new processes and unit operations across batch and continuous processing platforms.

What you bring to Takeda

• MS/PhD in Chemical or Process Engineering or Pharmaceutical Engineering.
• At least 5+ years‚Äô experience in a cGMP environment.
• At least 5+ years of pharmaceutical industry experience in small molecules is preferred.
• Self-motivated, good 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.
• Creating an environment that inspires and enables people.
• Focusing on the few priorities and delivering superior results.
• Elevating capabilities for now and the future.