Engineer IV, 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 R0137360 Date posted 10/25/2024 Location Boston, Massachusetts

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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 tobring 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 forthe process safety evaluationof chemical processes by independently planning and executing relevant experiments.He/She will lead process safety related technology transfer activities to vendors as well as independentlyinterpret and communicateprocess safety results.

Additionally, the successful candidate will be responsible for maintaining SMPD's kilolabfacilities to ensure the safe demonstration of the developed chemical processes ahead of technical transfer to the manufacturing organization.

Join Takeda as an Engineer IV, Process Safety.

How you will contribute:

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 Takeda's research and manufacturing facilities.
Prepare complex experimental protocols.
Collect and integrate relevant process safety data (e.g., calorimetry, pressure build-up, off-gassing), using for e.g. DSC, ARC, TSU, EasyMax, RC-1 and ARC into digital platforms for seamless data analysis and sharing, ensuring data complies with FAIR principles (Findable, Accessible, Interoperable, Reusable).
Work with external vendors to collect relevant process safety data.
Summarize and document results in an ELN as well as generate process safety test reports.
Conduct a HAZOP analysis and support phase appropriate process safety testing.
Partner with internal & external manufacturing organizations to ensure the safe scale-up of Takeda's processes.
Draft operating procedures, train SMPD staff and ensure adherence to quality standards.
Maintain SMPD's kilolabs, ensuring that they are safe, clean and functional.
Manage the kilolab inventory (including chemicals, reagents, equipment & consumables) and ensure adequate supplies are available.
Coordinate with contractors, vendors, and internal stakeholders to oversee the installation, commissioning, and qualification of kilolab equipment and systems.
Oversee internal manufacturing campaigns (e.g. review batch records, set-up equipment, support execution & cleaning).
Support local initiatives as directed by his/her supervisor and participate in global functional initiatives as appropriate.

Minimum Requirements/Qualifications:

Education and Experience:

Bachelor’s degree in Materials Sciences, Chemical Engineering, Mechanical Engineering with 5+ years relevant industry experience in process safety, manufacturing; chemical or pharmaceutical industry preferred.
Master’s degree in Materials Sciences, Chemical Engineering, Mechanical Engineering with 3+ years relevant industry experience in process safety, manufacturing; chemical or pharmaceutical industry preferred.
Previous experience working in a lab setting.
Previous experience working in a pilot plant setting a plus.
Previous experience in process safety in the pharmaceutical, agrochemical, fine chemical or related industry preferred.
Previous experience with HAZOPs and/or PHAs preferred.
Experience using relevant process safety equipment (e.g. DSC, RC1, EasymaxHFCal, ARC, Tsu) preferred.
Previous experience with software packages for process safety prediction (e.g., AKTS, Aspen Plus, gPROMS) a plus, focusing on the prediction of thermal, chemical, and kinetic properties.
Understanding of FAIR data principles (Findable, Accessible, Interoperable, Reusable) to drive efficient data management for safety modeling and analytics.

Knowledge and Skills:

Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information.
Teamwork - Ability to work well in a highly cross-functional team environment.
Communication - Able to expresses oneself clearly and concisely within team; documents issues and/or concerns concisely with colleagues;timely and effectively communicates issues to supervisor; technical writing skills to support contributing to internal technical documents.
Organization - Exercises good time management and prioritization skills and is able to successfully manage multiple tasks simultaneously.
Knowledge Sharing - Ability to capture organizational knowledge; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use.
Technical - Advanced proficiency in use of applicable lab equipment and operations.

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.

#LI-SB1

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:

96,600.00 - 151,800.00

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.

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.

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.

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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