Job Description

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Job Description

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 recognized as a technical resource/expert within SMPD and across Pharmaceutical Sciences and utilize their technical expertise to contribute across multiple projects, drive technical/scientific strategy and mentor junior engineers. The Associate Engineering Fellow will be leading complex programs and will be responsible for all aspects of reaction & particle engineering, including the development of scale down models for the study of unit operations, process safety evaluation as well as technical transfer to external contract manufacturing organizations. He or she will be collaborating closely with the Chemistry and Technology groups to apply enabling & emerging development and manufacturing technologies and will be responsible for helping shape the department’s technology roadmap, based on pipeline needs and current trends in research.

The ideal candidate will have deep experience in 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 Associate Engineering Fellow will have experience with building scale-down equipment and developing innovative advanced process control strategies for both batch and continuous processes. The ideal candidate will strive to continuously improve how pipeline projects are supported and will be developing new workflows to facilitate and accelerate process development, optimization and understanding as well as technical transfer to manufacturing, leveraging digital tools, automation, robotics and/or cobotics. He or she will represent Takeda with universities/industrial consortia and drive the group’s publication strategy.

How you will contribute:

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

• Collaborates closely with cross-functional teams, including process chemistry, analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs, to develop and implement effective process engineering strategies.

• Drives process optimization initiatives to improve sustainability, process efficiency, yield, quality, and cost-effectiveness, utilizing expertise in process chemistry and fundamental engineering principles.

• Oversees process scale-up activities from laboratory to pilot plant and commercial-scale production, ensuring smooth technology transfer and process validation.

• Has full accountability for all engineering aspects for complex pipeline projects.

• Initiates complex projects with extraordinary technical challenges and applies strong technical risk assessment skills.

• Owns a discipline/technical skill in its entirety and continues to develop expertise in other key technical skills.

• Conducts analysis of technical and conceptual risk through robust process characterization, failure mode analysis, and risk assessment methodologies, identifies trends and defines and champions process or scientific strategies.

• Benchmarks current trends in R&D and manufacturing technologies.

• Incorporates novel manufacturing, technologies, and industry trends as a key aspect of scientific strategy development.

• Leads small working groups as appropriate to address knowledge gaps in programs linking departmental strategy to strategies of other relevant functions.

• Identifies topics for initiatives and leads local/global initiatives on behalf of senior staff.

• Recognized as a technical leader/resource by the group and fosters development of technology skill sets within department and among junior staff.

• Acts as a mentor to junior staff.

• Leads the development of novel solutions for complex cross-functional data analysis, modeling, and engineering challenges.

• Contributes to departmental strategy around scientific improvement and new capabilities.

• Coordinates and leads technology transfer to internal or external manufacturing sites or vendors.

• Communicates with senior management of other functions on implementation of infrastructure, technology, work processes, or business processes.

• Responsible for authoring relevant sections of regulatory documents, validation plans, development reports, process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), process descriptions and peer reviewed manuscripts.

• Defines outsourcing strategy for department in conjunction with senior staff.

• Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver against pipeline goals.

• Attends pertinent workshops and conferences. Belongs to a national professional society, actively participates in local and national activities. Presents scientific posters or podia internally and externally to Takeda. Authors internal reports of publication quality and co-authors publishable manuscripts. Represents Takeda in relationships with universities and industrial consortia. Is an inventor on invention disclosures and patents. Authors publications. Contributes to and drives publication strategy within department. Establishes recognition as scientific leader within Takeda.

Minimum Requirements/Qualifications:

• A Ph.D. degree with 7+ years of pharmaceutical industry experience; an MS degree with 13+ years of pharmaceutical industry experience; or a BS degree with 15+ years of pharmaceutical industry experience. Degrees in chemical engineering required

• Extensive experience in the use of mathematical, both statistical and first principle, models as well as advanced process control systems preferred.

• Extensive experience in building reaction kinetic models as well as process models preferred.

• Extensive experience in building laboratory and pilot plant equipment preferred.

• Experience in crystallization process development and scale-up with an emphasis on polymorph, purity and particle size control a plus.

• Experience in the use and scale-up of milling technologies (both dry and wet) for particle size control preferred.

• Experience in the use of process analytical technologies (FT-IR, NIR, FBRM, UV-vis, etc.) required.

• Experience in building chemometric models preferred.

• Experience in developing continuous processes a plus.

• Sound knowledge of current Good Manufacturing Practices (cGMP).

• Experience working in a pilot plant a plus.

• Previous experience with the use of contract facilities and managing technical transfers.

• Experience in working in a multi-disciplinary team environment.

• Significant technical and strategic leadership and accomplishments

• Previous experience contributing to regulatory filings, preferably experience with late-stage filings.

• Proven scientific track record through presentations at scientific conferences and publication of peer reviewed manuscripts.

Knowledge and Skills:

• Able to troubleshoot critical issues or problems and determine the causes and possible solutions

• Ability to work well on global cross-functional team.

• Ability to expresses oneself clearly and concisely within t]]>

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