Job Description

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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 to bring life-changing therapies to patients worldwide.

Synthetic Molecule Process Development (SMPD) develops 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 Senior Staff Engineer – Process Modeling will join a dynamic and innovative team of engineers and scientists within SMPD’s Process Engineering & Technology Group.

Join Takeda as a Senior Staff Engineer – Modeling where you will have a strong background in chemical reaction engineering and will tackle and lead challenging problems in chemical reactions by leveraging expertise in reaction kinetics, transport phenomena, mathematical modeling, and reactor design. You will also lead and develop the 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) combined with mathematical models (both statistical and first principle) to enhance process understanding. This will enable the effective development, optimization, scale-up, and troubleshooting of processes using in-silico approaches. As part of the SMPD, you will report to Associate Engineering Fellow.

How you will contribute:

• Lead and contribute to the design, development, optimization, and scale-up of manufacturing processes for synthetic molecule drug substances using process modeling and simulation principles.

• Utilize advanced process modeling tools and digital twin functionalities, implementing model-based design of experiments for process characterization and risk assessment.

• Lead and develop 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.

• Partner 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.

• Recommend, justify and implement in silico tools and an in-silico first” approach to process development.

• Contribute to the democratization of modeling and simulation tools & results within global SMPD.

• Develop project or significant technical strategy and leverages technical skill(s) as a resource/expert within the department.

• Recognized as a technical expert and resource within the function 

• Contribute significantly and independently to project work as well as the development of platforms, which may include multiple projects within functional area.

• Proactively analyze technical issues and coordinate potential resolutions with project team members based on model and simulation predictions.

• Review, interpret and communicate data cross functionally within pharmaceutical sciences and project teams.

• Significant technical responsibility for a project area/technical program within the department and potentially across Pharmaceutical sciences.

• Stay current in novel process modeling and simulation tools and platforms, identify process trends and defines/champions process strategy.

• Influence and support initiatives related to driving scientific and technical improvement within the function and potentially cross-functionally.

• Identify topics for initiatives and lead local/global initiatives on behalf of senior staff.

• Author relevant sections of regulatory documents, validation plans, reports and peer reviewed manuscripts.

• Identify vendors and build relationships to gain access to technologies as needed to deliver on pipeline and platform technology goals.

• Manage key vendor relationships across multiple projects as appropriate, and proactively affects resolution of issues arising at vendors.

• Represent Takeda and is an active member on pre-competitive collaborations with academic and industrial partners.

Minimum Requirements/Qualifications:

Required:

• Bachelor's degree in Chemical Engineering or a related pharmaceutical science with 11+ years of relevant industry experience.

• Master's degree in Chemical Engineering or a related pharmaceutical science with 9+ years of relevant industry experience.

• 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 chemical reaction engineering and catalysis, with proven ability to demonstrate skills in these fields.

• Strong knowledge and understanding of transport phenomena and thermodynamics.

• Extended experience with commercially available reaction kinetic modeling software such as Ansys, ReactionLab, Dynochem, and gPROMS.

• 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; adjust 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.

TRAVEL REQUIREMENTS: May require approximately 5-10% travel.

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.

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