Sr. Staff Engineer

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Job Description

Synthetic Molecule Process Development (SMPD) is responsible for the development of robust and cost-effective processes for the manufacture of new small molecule pharmaceuticals, along with methods for achieving and controlling high standards of purity and quality.

The successful candidate will be responsible for all aspects of reaction & particle engineering including the development of scale down models for the study of unit operations as well as technical transfer to external contract manufacturing organizations. He/ she will have deep experience in using process analytical technologies (PAT) in combination with mathematical models (both statistical & first principle) to enhance process understanding to effectively develop/ optimize/ scale-up and troubleshoot processes.

The Senior Engineer will have experience building scale-down equipment and developing innovative advanced process control strategies for both batch and continuous processes.

Be recognized as a technical resource/expert within SMPD and across Pharmaceutical Sciences, will serve as a subject matter expert in one or more key areas (e.g., crystallization, reaction engineering, mixing, heat transfer, drying), provide guidance to junior engineers, and contribute to strategic initiatives to advance the organization’s process development capabilities. The role involves close collaboration with process chemistry, analytical development, manufacturing, formulation scientists, quality, and regulatory functions to ensure the successful progression of drug substance candidates from early clinical phases through to commercial launch.

The Senior Engineer will be responsible for benchmarking current trends in research, development and manufacturing technologies, developing initiating and/or participating at a high level in projects that involve extraordinary, well-considered risks along with scientific/technical challenges, as well as directing and managing outsourcing across a product platform, as appropriate.

Accountabilities

• Lead the engineering design, development, and optimization of synthetic processes for small molecule active pharmaceutical ingredients (APIs).
• Apply chemical engineering fundamentals (mass/energy balances, kinetics, thermodynamics, fluid dynamics, mixing, heat transfer, crystallization, etc.) to ensure scalability and robustness of processes.
• Plan and execute laboratory and pilot-scale studies to support process development, scale-up, and validation.
• Implement Process Analytical Technology (PAT) and Quality by Design (QbD) principles to enable process understanding and control strategies.
• Lead the technology transfer from development to cGMP manufacturing sites, ensuring process robustness and compliance.
• Partner with process chemists and manufacturing operations to solve technical challenges, and resolve technical issues during scale-up, batch execution, and validation campaigns.
• Provide on-site support at manufacturing facilities during key technical transfers, troubleshooting, and regulatory inspections.
• Identify and implement opportunities for efficiency, cost reduction, sustainability, and innovation in process development and manufacturing.
• Support the development of new tools, methodologies, and platforms to accelerate small molecule development. Contribute to the long-term capability building in areas such as digitalization, automation, and modeling/simulation.
• Identify topics for initiatives and leads local/global initiatives on behalf of senior staff.
• Own a discipline/technical skill in its entirety and continue to develop expertise in other key technical skills. Recognized as a technical expert and resource within function.
• Review, interpret and communicate data cross functionally within pharmaceutical sciences and…