Staff Engineer, Modeling

Takeda•Boston, MA

About The Position

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 Staff Engineer – Process 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 chemical reaction engineering and will tackle challenging problems in chemical reactions by leveraging expertise in reaction kinetics, transport phenomena, mathematical modeling, and reactor design. Additionally, the Staff Engineer will be involved in developing scale-up and scale-down models for studying unit operations using both first principle and data-based models. The role includes the application of process analytical technologies (PAT) in combination with mathematical models (both mechanistic and statistical) to enhance process understanding and enable data-rich experimentation. These approaches will drive the design, optimization, scale-up, and troubleshooting of synthesis processes, ensuring robust pharmaceutical manufacturing through digital and in-silico methodologies.

Requirements

Bachelor's degree in Chemical Engineering or a related pharmaceutical science with 5+ years of relevant industry experience.
Master's degree in Chemical Engineering or a related pharmaceutical science with 3+ years of relevant industry experience.
Ph.D. in Chemical Engineering or a related pharmaceutical science with 0+ years of relevant industry experience.
Strong knowledge and understanding of chemical reaction engineering and catalysis, with proven ability to demonstrate skills in these fields.
Strong knowledge and understanding of transport phenomena and thermodynamics.
Experience with commercially available reaction kinetic modeling software such as ReactionLab, Dynochem, gPROMS and COMSOL.
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.
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

Nice To Haves

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).

Responsibilities

Contributes to the design, development, optimization, and scale-up of manufacturing processes for synthetic molecule drug substances using process modeling and simulation principles.
Utilizes advanced process modeling tools and digital twin functionalities, implementing model-based design of experiments for process characterization and risk assessment.
Develops experimental designs and workflows for model development, validation, and verification.
Collaborates with cross-functional and external partners to develop and deploy digital twins of unit operations.
Partners with Automation, Manufacturing, Process Engineers, and PAT experts to develop modeling and simulation (M&S) solutions that can be deployed across the global organization for in-silico process design, development, and optimization.
Recommends, justifies and implements in silico tools and an " in-silico first” approach to process development
Responsible for authoring relevant sections of regulatory documents, validation plans, reports and peer reviewed manuscripts.
Proactively analyze technical issues and coordinate potential resolutions with project team members based on model and simulation predictions.

Benefits

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.

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