Senior Staff Engineer, Process Safety
Company: Takeda Pharmaceutical
Location: Boston
Posted on: October 29, 2024
Job Description:
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's and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.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. -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 information and
determine 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. -#LI-SB1Takeda Compensation and
Benefits SummaryWe 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, MAU.S.
Base Salary Range:$133,000.00 - $209,000.00The 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-term incentives. 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 StatementTakeda 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.LocationsBoston, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Leominster , Senior Staff Engineer, Process Safety, Other , Boston, Massachusetts
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