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Senior Staff Engineer, Process Safety

Boston, Massachusetts
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  • Job Level: Senior
  • Travel: 5-10%

The Pharmaceutical Sciences (Pharm Sci) organization is an integral part of global R&D at Takeda, translating science into therapeutic products for patients. When you join Pharm Sci, you become part of a team dedicated to bringing our products to life for our patients through innovation, dedication and talent while minimizing environmental impact.

We work as a member of Takeda’s Global Program Team (GPT) and take full ownership of Chemistry, Manufacturing & Control (CMC) activities — driving product development from bench to bedside.

The Pharm Sci team focuses on executing and enhancing business processes and partnering with key stakeholders and industry leaders to boldly deliver an increasingly complex portfolio. Always looking through a sustainability lens to protect our planet, we are embracing new ways of working, excelling in our data and digital transformation, building differentiated capabilities (CMC Acceleration), delivering innovative medical devices, and advancing an inclusive, innovative culture.

It is an exciting time to be in Pharm Sci. Join our journey and change the lives of patients!

Job ID R0137358 Date posted 10/25/2024 Location Boston, Massachusetts

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

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 evaluationduring different phases of process development. He/She will have deep experience in using relevant process safety analysis technologies and developing thermodynamic and kinetic modelsto reduce safety risks during development and scale-up.He/She will also be responsible fordeveloping SMPD’s process safety database and usingan in-silico first approach to enhance process understanding while reducing the needfor 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 aboutprocess 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. 

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:

Education and Experience:

  • 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 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 informationanddetermine causes and possible solutions.

  • Teamwork - Ability to work well on global cross-functional teams. 

  • Communication Skills -Able to expresses 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.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Base Salary Range:

133,000.00 - 209,000.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes
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Where you fit in

Our teams are experienced in medicinal chemistry, multi-step synthesis, multimodal genetics, genomics datasets, pharmacokinetics and more. So wherever your expertise and passion lie, your work will have tangible outcomes, advancing an innovative pipeline that serves unmet needs.

We're delving deeper than ever inside the human body and its microbiome, implementing innovative approaches to deliver high-quality products that treat a range of illnesses, including IBD and cancer.

In our diverse, forward-thinking culture, we're constantly embracing new ways of working:

  • Partnering with research teams, GPTs, business development and our commercial partners in GMS/GQ
  • Supporting all stages of pre-clinical and clinical development
  • Providing enabling technologies, including formulation and delivery strategies, analytical expertise and IP
  • Developing processes to manufacture high-quality Clinical Trial Material and other
  • Focusing on broad therapeutic areas on multiple device platforms: Advanced Delivery Devices, Home & Point-Of-Care Diagnostics, Software & Connectivity for eHealth devices and state-of-the-art Medical Devices & Combination Products

On our team in Pharmaceutical Sciences, you’ll notice a big difference in your own life, too. You’ll be supported to develop your career. You'll connect with brilliant minds and be recognized for your accomplishments. Your curiosity, skills and dedication will have a place and a purpose. So even when you’re exploring the smallest of details, your world will be bigger than ever.

  • Perform cell processing operations

  • Support clean room activities

  • Ensure equipment maintenance

  • Support investigations in deviations

Along with incredibly passionate colleagues, there’s a clear commitment to invest in the best facilities and the right equipment needed to successfully perform world-class science.
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Christina Alves - Head of Biotherapeutics Process Development

Within Takeda, there’s a lot of room for disruption and challenging how things have been done before.
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Briana Rawson - Lead, Human Factors Engineer

I love that I get to connect smaller, newer ventures with Takeda’s reputation and resources so that we can develop innovative ways of diagnosing and managing the conditions of patients with unmet needs.
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Rachel Whitaker - Principal Engineer, Diagnostic Devices

The heart of our work

Leading with innovation

Our pipeline

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.

Learn more

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

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About our location

Boston, Massachusetts


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