Senior Staff Engineer, Process Safety

$133,000 - $133,000/Yr

Takeda Pharmaceutical Company - Boston, MA

Full-time - Senior

Boston, MA

Chemical Manufacturing

About the position

The Senior Staff Engineer, Process Safety at Takeda will lead the process safety team and activities within the Synthetic Molecule Process Development (SMPD) organization. This role focuses on developing robust and cost-effective processes for the manufacture of new small molecule pharmaceuticals, ensuring high standards of safety and quality. The successful candidate will utilize their expertise in process safety analysis technologies and thermodynamic modeling to mitigate safety risks during process development and scale-up, while also managing a centralized process safety database and collaborating with cross-functional teams to enhance safety frameworks throughout the drug development lifecycle.

Responsibilities

• Lead the process safety team & activities.
• Develop suitable workflows and phase-appropriate testing plans for identifying potential hazards of reactive chemicals and evaluating chemical hazards for combustible powders.
• Work 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 and in silico models 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 comprehensive digital process safety reports.
• Collaborate with cross-functional teams to embed data-driven process safety frameworks into the drug substance development lifecycle.
• Review digital safety reports and data models to identify potential safety risks and design mitigation strategies.
• Manage key vendor relationships for advanced process safety testing.
• Lead technology development and workflow initiatives to improve efficiency.

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 in silico process development and predictive models for proactive safety interventions.
• Strong understanding of FAIR data principles for efficient data management.

Nice-to-haves

• Experience working in a pilot plant.
• Previous experience with the use of contract facilities and managing technical transfers.
• Sound knowledge of current Good Manufacturing Practices (cGMP).
• 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
• Sick time and paid vacation accrual