Takeda Pharmaceutical Company - Boston, MA

posted 2 months ago

Full-time - Senior
Boston, MA
Chemical Manufacturing

About the position

The Senior Staff Engineer, Process Safety at Takeda is responsible for leading the process safety team and activities within the SMPD - Process Engineering & Technology team. This role focuses on developing workflows and testing plans to identify potential hazards in chemical processes, ensuring safe scale-up of pharmaceutical intermediates and active products. The engineer will integrate process safety data into digital platforms, utilize thermokinetic software for safety calculations, and collaborate with cross-functional teams to enhance safety frameworks throughout the drug development lifecycle.

Responsibilities

  • Lead process safety team & activities.
  • Develop suitable workflows and fit for purpose, phase appropriate testing plans for identifying potential hazards of reactive chemicals, chemical reactions, and waste streams.
  • Conduct chemical hazard evaluations for combustible powders and assess material compatibility.
  • Collaborate with process chemists and engineers to evaluate hazards for safe scale-up of chemical processes.
  • Collect and integrate relevant process safety data into digital platforms for analysis and sharing.
  • Use thermokinetic software to calculate critical process parameters and drive proactive safety interventions.
  • Develop and manage centralized process safety databases for predictive safety analysis.
  • Lead the development of digital protocols for conducting HAZOP analyses.
  • Document and summarize safety results in an Electronic Lab Notebook (ELN) and generate digital process safety reports.
  • Collaborate with internal and external teams to embed data-driven safety frameworks into drug substance development.
  • Review digital safety reports to identify potential risks and design mitigation strategies.
  • Manage key vendor relationships for advanced process safety testing.
  • Lead technology development initiatives to improve efficiency.
  • Stay current on process safety science and technology.

Requirements

  • Ph.D. degree with 3+ years of industry experience; MS degree with 9+ years; or BS degree with 11+ years of industry experience in Material Sciences, Chemical Engineering, or Mechanical Engineering.
  • Previous experience in process safety in the pharmaceutical, agrochemical, or fine chemical industry.
  • Experience in HAZOPs and/or PHAs with a proven ability to lead safety assessments using digital tools.
  • Strong background in kinetic modeling and mechanistic models for identifying critical safety limits in reaction chemistry.
  • Experience with software packages for process safety prediction (e.g., AKTS, Aspen Plus, gPROMS) preferred.
  • Knowledge of FAIR data principles for efficient data management.
  • Sound knowledge of current Good Manufacturing Practices (cGMP) preferred.

Nice-to-haves

  • Experience working in a pilot plant.
  • Previous experience with contract facilities and managing technical transfers.
  • Experience in working in a multi-disciplinary team environment.
  • Proven scientific track record through presentations at scientific conferences and publication of peer-reviewed manuscripts.

Benefits

  • Medical, dental, and vision insurance
  • 401(k) plan with company match
  • Short-term and long-term disability coverage
  • Basic life insurance
  • Tuition reimbursement program
  • Paid volunteer time off
  • Company holidays
  • Well-being benefits
  • Up to 80 hours of sick time per year
  • Accrual of up to 120 hours of paid vacation for new hires
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