Senior Staff Engineer, Modeling

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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

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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