Associate Engineering Fellow, Process Engineering
4 days ago
At Takeda Pharmaceutical, we are seeking a highly skilled and experienced Associate Engineering Fellow to join our Process Engineering team. As a key member of our team, you will be responsible for developing and implementing process engineering strategies to improve sustainability, process efficiency, yield, quality, and cost-effectiveness.
Key Responsibilities:- Develop and implement process engineering strategies to improve sustainability, process efficiency, yield, quality, and cost-effectiveness.
- Collaborate closely with cross-functional teams, including process chemistry, analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs.
- Drive process optimization initiatives to improve sustainability, process efficiency, yield, quality, and cost-effectiveness.
- Oversee process scale-up activities from laboratory to pilot plant and commercial-scale production, ensuring smooth technology transfer and process validation.
- Have full accountability for all engineering aspects for complex pipeline projects.
- Initiate complex projects with extraordinary technical challenges and apply strong technical risk assessment skills.
- Own a discipline/technical skill in its entirety and continue to develop expertise in other key technical skills.
- Conduct analysis of technical and conceptual risk through robust process characterization, failure mode analysis, and risk assessment methodologies.
- Benchmark current trends in R&D and manufacturing technologies.
- Incorporate novel manufacturing, technologies, and industry trends as a key aspect of scientific strategy development.
- Lead small working groups as appropriate to address knowledge gaps in programs linking departmental strategy to strategies of other relevant functions.
- Identify topics for initiatives and lead local/global initiatives on behalf of senior staff.
- Recognized as a technical leader/resource by the group and foster development of technology skill sets within department and among junior staff.
- Act as a mentor to junior staff.
- Lead the development of novel solutions for complex cross-functional data analysis, modeling, and engineering challenges.
- Contribute to departmental strategy around scientific improvement and new capabilities.
- Coordinate and lead technology transfer to internal or external manufacturing sites or vendors.
- Communicate 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.
- Define outsourcing strategy for department in conjunction with senior staff.
- Proactively identify vendors and build relationships to gain access to technologies as needed to deliver against pipeline goals.
- Attend pertinent workshops and conferences. Belong to a national professional society, actively participate in local and national activities. Present scientific posters or podiums internally and externally to Takeda. Author internal reports of publication quality and co-author publishable manuscripts. Represent Takeda in relationships with universities and industrial consortia. Be an inventor on invention disclosures and patents. Author publications. Contribute to and drive publication strategy within department. Establish recognition as a scientific leader within Takeda.
- 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.
- Able to troubleshoot critical issues or problems and determine the causes and possible solutions.
- Ability to work well on global cross-functional teams.
- Ability to express oneself clearly and concisely within teams; document issues and/or concerns concisely and comprehensively; adjust communication style as appropriate for the audience timely and effectively communicate with senior management; technical writing skills to support authorship of internal/external and approval of internal technical documents.
- Excellent time management and prioritization skills to balance several project and departmental objectives.
- Recognized specialist in defined scientific area or areas.
- Ability to capture knowledge within the organization; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use.
- Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events and communicating new scientific trends. Interact with external vendors for projects.
- Develop and use knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives.
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