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Takeda

Senior Staff Engineer, Modeling

Reposted 2 Days Ago
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Hybrid
Boston, MA
137K-215K Annually
Senior level
Hybrid
Boston, MA
137K-215K Annually
Senior level
The Senior Staff Engineer will lead crystallization process development, utilizing modeling techniques to optimize particle engineering for pharmaceuticals.
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Job Description
OBJECTIVE:
Synthetic Molecule Process Development (SMPD) is responsible for developing robust, cost-effective processes for new small-molecule pharmaceuticals, including methods to achieve and control high standards of crystal form, particle size distribution (PSD), and product quality. The Senior Staff Engineer - Crystallization & Particle Engineering (Modeling) will join a dynamic and innovative team of engineers and scientists within SMPD's Process Engineering & Technology Group.
The successful candidate will have a strong background in crystallization process development and population balance modeling (PBM). They will lead and tackle challenging problems in particle engineering by leveraging expertise in crystallization kinetics, mass/heat transfer, mathematical modeling, and crystallization design. Additionally, the Senior Staff Engineer will establish scale-up and scale-down models for crystallization operations, using both first-principle and data-driven approaches.
The role includes the application of process analytical technologies (PAT) combined with mathematical models (both statistical and first principle) to enhance process understanding. This in turn will enable effective development, optimization, scale-up, and troubleshooting of crystallization processes using in-silico approaches.
ACCOUNTABILITIES:
  • Leads and contributes to the design, development, optimization, and scale-up of crystallization processes for synthetic molecule drug substances, leveraging advanced modeling, simulation, and population balance modeling approaches.
  • Develops, implements, and validates predictive crystallization models (mechanistic, data-based or hybrid) to predict and control particle size distribution, morphology, purity, and polymorphic form.
  • Designs and executes experimental workflows, integrating in-line and off-line process analytical technologies (PAT), for data-rich model development and verification.
  • Collaborates cross-functionally with Automation, Manufacturing, Process Engineering, and analytical experts to develop and deploy digital twins for crystallization and particle engineering processes.
  • Drives adoption of an "in-silico first" approach, recommending, justifying, and implementing robust crystallization modeling tools and workflows across the organization.
  • Provides expert technical leadership within the crystallization modeling domain, influencing strategic direction and independently resolving complex technical issues through predictive modeling.
  • Reviews, interprets, and communicates modeling outcomes and experimental data to multidisciplinary teams and stakeholders to support informed decision-making and process improvements.
  • Authors technical reports, validation documents, regulatory filings, and peer-reviewed manuscripts related to crystallization modeling and particle engineering methodologies.
  • Maintains awareness of emerging trends and tools in crystallization modeling, proactively identifies relevant vendor solutions, and actively participates in academic and industry collaborations to advance modeling capabilities.
  • Champions knowledge-sharing and democratization of crystallization modeling and simulation methodologies, providing training and guidance to support broader technical capability building across the department and global organization.

EDUCATION, EXPERIENCE AND SKILLS:
Education and Experience:
Required:
  • Ph.D. or postdoctoral fellowship in Chemical Engineering or a related pharmaceutical science with 3+ years of relevant industry experience.
  • Strong knowledge and understanding of crystallization, filtration, drying processes, with proven ability to demonstrate skills in these fields.
  • Strong knowledge and understanding of transport phenomena and thermodynamics.
  • Extended experience with commercially available crystallization and particle engineering modeling software such as gPROMS, Aspen, Ansys, or Dynochem.
  • Extended experience with commercially available software for computational fluid dynamics (CFD) modeling such as Ansys, Star CCM+, MStar CFD.
  • Proficient in communicating and data collection from systems such as sensors, controllers, and industrial systems.
  • Experience, with Matlab, Python, R, SQL, and good coding practices.

Preferred:
  • Experience with common statistical methods, basic data science principles, and AI/ML methodologies.
  • Hands-on experience in wet lab process development.
  • Experience in multivariate analysis and Principal Component Analysis (PCA).
  • Understanding of synthetic molecule process development activities.
  • Understanding of current Good Manufacturing Practices (cGMP).

Knowledge and Skills:
  • Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems, and determine causes and possible solutions
  • Teamwork -- Ability to work well in highly cross functional team environment and across global line functions.
  • Communication Skills -Able to expresses one's self 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 issues to supervisor; technical writing skills to support authorship of 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
  • Resource Management -Ability to manage one's time within individual, departmental, and corporate goals and timelines; management of internal and external resources (vendors)
  • External Involvement - Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events
  • Technical - Subject matter expertise and knowledge of applicable process modeling and simulation tools

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:
$137,000.00 - $215,270.00
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-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 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
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Top Skills

Ansys
Aspen
Dynochem
Gproms
Matlab
Mstar Cfd
Python
R
SQL
Star Ccm+
HQ

Takeda Cambridge, Massachusetts, USA Office

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