Senior Engineer

3 weeks ago

Boston, United States Takeda Pharmaceutical Full time
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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

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 process safety evaluation during diffe rent phases of process development . He/ S he will have deep experience in using relevant process safety analysis technologies and developing thermodynamic and kinetic model s to reduce safety risks during development and scale-up. He/She will also be responsible for developing SMPD 's process safety database and using an in-silico first approach to enhance process understanding while reducing the need for extensive experiments.

The Senior Engineer will be recognized as a technical resource/expert within SMPD and utilize his/her technical expertise to contribute across multiple projects and drive technical/scientific strategy. He/She will be responsible for benchmarking current trends about process safety in research, development and manufacturing technologies, developing initiating and/or participating at a high level in projects, as well as directing and managing outsourcing across a product platform, as appropriate .

Join Takeda as a Senior Staff Engineer, Process Safety where you will lead the process safety team and activities. Lead the process safety team & activities. Develop suitable workflows and fit for purpose, phase appropriate testing plans for: 1. The identification of potential hazards of reactive chemicals, chemical reactions and waste streams. The chemical hazard evaluation for combustible powders. Assessing material compatibility. Work with process chemists and engineers to perform a thorough evaluation of all known and potential hazards for the safe scale-up of chemical processes for preparing pharmaceutical intermediates and active products in both Takeda's research and manufacturing facilities. Collect and integrate relevant process safety data (e.g., calorimetry, pressure build-up, off-gassing) into digital platforms for seamless data analysis and sharing, ensuring data complies with FAIR principles (Findable, Accessible, Interoperable, Reusable). Use thermokinetic software and in silico models to calculate critical process parameters, such as runaway reactions, Self Accelerating Decomposition Temperature (SADT), and Time to Maximum Rate under Adiabatic conditions ( TMRad ), driving proactive safety interventions. Develop and manage centralized process safety databases, ensuring data is easily accessible and usable for predictive safety analysis, while also creating tools to support an in-silico first approach to process safety assessment, reducing the need for excessive physical experiments. Lead the development of digital protocols for conducting HAZOP analyses, utilizing data-driven insights to enhance hazard identification and risk mitigation in both new and scaled processes. Document and summarize safety results in an Electronic Lab Notebook (ELN) and generate comprehensive digital process safety reports, ensuring consistent and accessible data tracking and compliance documentation. Collaborate with cross-functional teams to embed data-driven process safety frameworks into the overall drug substance development lifecycle, from lab scale to full production. Collaborate with internal and external manufacturing teams, leveraging data analytics AI/ML and predictive modeling to ensure the safe scale-up of processes, identifying risks before scale-up stages. Review digital safety reports and data models to identify potential safety risks and design data-driven mitigation strategies, ensuring continuous process improvement and enhanced safety outcomes. Manage key vendor relationships and lead their engagement to carry out advanced process safety testing. Remain current on process safety science and technology.

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