Staff Engineer, Process Engineering
PharmaRegulatory AffairsQuality Assuranceheoremacroinformaws
Job description
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. 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+ years of pharmaceutical industry experience; or a BS degree with 5+ of pharmaceutical industry experience. · Demonstrated hands-on wet-lab experience, including safe execution of laboratory experiments and collection and interpretation of experimental data is required. · A proven scientific track record through presentations at scientific conferences and publication of peer reviewed manuscripts is required. Preferred: · Experience in working in a multi-disciplinary team environment is preferred. · Experience in building laboratory and/or pilot plant equipment is preferred. · Experience working in a pilot plant is preferred. · Experience developing and applying first-principles, statistical, and/or data-driven models to guide experimentation and using experimental data to refine and validate models is preferred. Knowledge and Skills: · Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems using appropriate information and determine causes and possible solutions · Teamwork -- Ability to work well on global cross-functional teams. · Communication Skills -Able to express oneself 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 with senior management; technical writing skills to support authorship and approval of internal technical documents · Organization – Exercises good time management and prioritization skills to balance multiple project and departmental objectives · Technical - Subject matter expertise in a specific scientific area or areas. · Knowledge
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