Staff Engineer, Process Engineering

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Job Description Staff Engineer

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 three 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, sustainable and cost-effective processes for the manufacture of new synthetic molecule pharmaceuticals, along with methods for achieving and controlling high standards of purity and quality.

The successful candidate will be responsible for aspects of reaction & particle engineering including the development of scale down models for the study of unit operations as well as technical transfer to external contract manufacturing organizations. They will be responsible for using process analytical technologies (PAT) in combination with mathematical models (both statistical & first principle) to enhance process understanding to effectively develop/optimize/scale-up and troubleshoot processes.

The Staff Engineer will develop scale-down equipment and help implement innovative advanced process control strategies for both batch and continuous processes.

They will be recognized as a technical resource within SMPD and utilize his/ her technical expertise to contribute across pipeline projects. The Staff Engineer will also be responsible for helping advance the department’s key technologies and define him/ herself as a subject matter expert in specific areas. He/ she will be responsible for managing outsourced activities as well as representing Takeda in pre-competitive collaborations with academic and industrial partners.

Accountabilities:
· Independently designs and executes complex experimental protocols and reports results.
· Owns a technical skill in its entirety and contributes significantly and independently to project work which may include multiple projects within functional area.
· Provides technical leadership to project teams within area of expertise and commits resources to execute specific project tasks.
· Reviews, interprets and communicates data cross-functionally within pharmaceutical sciences and project teams.
· Assists with the development of project strategy and communicates complex data/decisions within department and cross functionally as necessary.
· Identifies process trends, recommends and implements new technologies and innovations.
· Recognized as a technical expert and resource within function.
· Coordinates and leads technology transfer to internal or external manufacturing sites.
· Responsible for authoring relevant sections of regulatory documents, validation plans, reports and peer reviewed manuscripts.
· Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals.
· Manages key vendor relationships across multiple projects as appropriate and proactively affects resolution of issues arising at vendors.

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

Education and Experience:

Required:

· Degrees in chemical engineering are required. A Ph.D. degree with 0+ years of academic, post-doctoral or pharmaceutical industry experience; an MS degree with 3+…