Senior Staff Engineer, Process Safety

Company: Takeda
Location: Boston
Posted on: November 13, 2024

Job Description:

Job DescriptionAbout 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 different phases of process development. He/She will have deep experience in using relevant process safety analysis technologies and developing thermodynamic and kinetic models 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.How you will contribute:

• 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. 2. The chemical hazard evaluation for combustible powders. 3. 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.
• Lead technology development and workflow initiatives to implement new capabilities and improve efficiency.
• Remain current on process safety science and technology.
• Maintain active involvement in key professional societies through conference participation and peer-reviewed publications.Minimum Requirements/Qualifications:
  • A Ph.D. degree with 3+ years of industry experience; an MS degree with 9+ years of industry experience; or a BS degree with 11+ years of industry experience. Degrees in Material Sciences, Chemical Engineering or Mechanical Engineering required.
  • Previous experience in process safety in the pharmaceutical, agrochemical, fine chemical or related industry required.
  • Experience in HAZOPs and/or PHAs required, with a proven ability to lead safety assessments using digital tools.
  • Previous experience with software packages for process safety prediction (e.g., AKTS, Aspen Plus, gPROMS) preferred, focusing on the prediction of thermal, chemical, and kinetic properties.
  • Strong background in kinetic modeling and the use of mechanistic models for identifying critical safety limits in reaction chemistry, ideally for pharmaceutical or chemical processes.
  • Experience in leveraging digitalization strategies, such as automated data pipelines, real-time monitoring systems, and AI-driven predictive models, to enhance process safety and reduce risk.
  • Knowledge of in silico process development and the application of predictive models for proactive safety interventions and process optimization.
  • Strong understanding of FAIR data principles (Findable, Accessible, Interoperable, Reusable) to drive efficient data management for safety modeling and analytics.
  • Sound knowledge of current Good Manufacturing Practices (cGMP) preferred.
  • Experience working in a pilot plant a plus.
  • Previous experience with the use of contract facilities and managing technical transfers a plus.
  • Experience in working in a multi-disciplinary team environment.
  • Proven scientific track record through presentations at scientific conferences and publication of peer-reviewed manuscripts.Knowledge and Skills:
    • Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems using appropriate information and determine causes and possible solutions.
    • Teamwork - Ability to work well on global cross-functional teams.
    • Communication Skills - Able to express oneself clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates with senior management; technical writing skills to support authorship and approval of internal technical documents.
    • Organization - Exercises good time management and prioritization skills to balance multiple project and departmental objectives.
    • Technical - Subject matter expertise in a specific scientific area or areas.
    • Knowledge Sharing - Ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use.
    • External Involvement - Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. Interacts with external vendors for projects.
    • Leadership Skills - Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives.More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
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Keywords: Takeda, Portland , Senior Staff Engineer, Process Safety, Engineering , Boston, Maine