Associate Engineering Fellow Process Development

4 days ago


Cambridge, Massachusetts, United States Takeda Full time
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 his/her technical expertise to contribute across multiple projects, drive technical/scientific strategy, and mentor junior engineers.

The Associate Engineering Fellow will lead complex programs and 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.

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.

Key Responsibilities
  • 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 podiums 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.


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