技術系（機械設計・製造技術） - プラントエンジニア（電気）
技術系（機械設計・製造技術） - プラントエンジニア（機械）
メディカル・バイオ - ＣＭＣ薬事

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 responsible for leading a group of Engineers 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 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 and drive technical/scientific strategy.

The Associate Director 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 successful candidate will be responsible for maintaining and growing the department’s strategic relationships with our outsourcing partners as well as directing and managing outsourcing across a product platform, as appropriate.

■休日：完全週休二日制, 祝日, 年末年始, 土, 日

※英文レジュメが必要となります※

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.

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.


Education and Experience:

A Ph.D. degree with 3+ years of academic, post-doctoral or pharmaceutical industry experience; an MS degree with 9+ years of pharmaceutical industry experience; or a BS degree with 11+ years of pharmaceutical industry experience. Degrees in chemical engineering required.
Experience in the use of mathematical, both statistical and first principle, models as well as advanced process control systems preferred
Experience in building reaction kinetic models as well as process models preferred.
Experience in building laboratory and pilot plant equipment a plus
Experience in crystallization process development and scale-up with an emphasis on form, 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 a plus
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) preferred
Experience working in a pilot plant a plus
Previous experience with the use of contract facilities and managing technical transfers a plus
Experience in working in a multi-disciplinary team environment
Proven scientific track record through presentations at scientific conferences and publication of pier reviewed manuscripts


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 expresses one’s self 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 Sharing - Ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use
Resource Management -Project management skills; ability to manage one’s time within individual, departmental
External Involvement – Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. Interacts with external vendors for projects
Leadership Skills – Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives.

■職種未経験者：不可