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Principal Scientist Process Research Synthetic Molecule Proce…
| Hiring Company | 武田薬品工業株式会社 |
| Location | Kanagawa Prefecture |
| Job Type | Permanent Full-time |
| Salary | 5.5 million yen ~ 9 million yen |
Job Description
【求人No NJB2205642】
ACCOUNTABILITIES
Designs scalable synthetic processes for synthetic DS and phase appropriate strategies for reaction optimization.
Analyzes and interprets scientific data independently and solves synthetic chemistry problems.
Independently develops and executes plans for process research and development as well as non GMP/GMP preparation of gram to kilogram quantities of APIs intermediates impurities and reference standards and/or manages such activities at CDMOs.
Leads all or part of the SMPD efforts on a program and represents SMPD in cross functional meetings.
Actively builds necessary cross functional and cross site relationships in support of early stage development.
Plays an important role as a subject matter expert in a global cross functional project team and collaborates with other functions in support of the development and implementation of an overall CMC strategy.
Establishes metrics and has accountability for progression of process chemistry related activities against project goals; regularly determines deadlines and objectives.
Prepares drug substance related regulatory documents for IND and RTQ.
As necessary prepares experimental procedures for patent applications and scientific reports as well as tech transfer documents in support of SMPD internal program transfer and collaborations with CDMOs.
TRAVEL AND OTHER REQUIREMENTS
Some domestic and international travels to internal meetings or external vendor/CDMO sites may be necessary.
Ability to participate early morning and/or late evening tele/video conferences.
General Requirements
| Minimum Experience Level | No experience |
| Career Level | Mid Career |
| Minimum English Level | Business Level |
| Minimum Japanese Level | Native |
| Minimum Education Level | Post Grad Degree (PHD/MBA etc) |
| Visa Status | Permission to work in Japan required |
Required Skills
EDUCATION EXPERIENCE KNOWLEDGE COMPETENCIES AND SKILLS Education Ph.D degree in organic chemistry and 7+ years of industry experience in the fields of process chemistry or M.S. degree in organic chemistry and 10+ years of industry experience in the fields of process chemistry. Additional study or post doctoral research experience abroad is preferred. Experience and Knowledge Expert understanding of a wide range of synthetic organic chemistry including reaction mechanistic aspects and synthetic route design （retrosynthetic analysis） paired with excellent laboratory skills. A high level of proficiency in multi step synthesis purification and characterization of complex organic molecules using the latest techniques. Experience with synthetic route scouting DS process development and scale up manufacturing under cGMP. Experience in managing DS development and manufacturing activities at external CDMOs. Experience in the use of technologies （e.g. flow chemistry photo redox chemistry Process Analytical Technologies （PAT） such as FT IR NIR FBRM UV vis etc. automation artificial intelligence kinetic modeling etc.） and an interest in application to early stage development programs are preferred. Knowledge of regulatory requirements in ICH and experience with authoring and reviewing CMC documentation for IND/NDA is preferred. Competencies and Skills Leadership ・ Identifies opportunities and demonstrates initiative towards the accomplishment of department/function goals and objectives. Problem Solving ・ Ability to troubleshoot critical issues or problems using appropriate information and determine causes and possible solutions. Communication ・ Communicates complex information clearly and engagingly; documents issues and/or concerns concisely with colleagues; asks for and provides the right amount of information to meet the needs of management direct reports and project teams; adjusts communication style as appropriate for the audience; proactively and effectively communicates with stakeholders and management; technical writing skills to support authorship and approval of internal technical documents. Teamwork ・ Must have a collaborative mindset to build a network of relationships with people in a variety of functions and roles; leverages formal and informal networks to accomplish goals; promotes shared responsibility for getting things accomplished across our organization. Technical ・ Subject matter expertise in one or more specific scientific area（s） of organic chemistry as well as multi step synthesis of pharmaceutically active ingredients. Resource Management ・ Ability to manage timelines as well as individual departmental and project goals; effective management of internal and external resources （CDMOs）. Development/Growth ・ Possesses self awareness and a learning oriented mindset with a desire to continually build and grow leadership management and technical skills to elevate personal team and organizational performance and capabilities.Job Location
- Kanagawa Prefecture
Work Conditions
| Job Type | Permanent Full-time |
| Salary | 5.5 million yen ~ 9 million yen |
| Work Hours | 09:00 ～ 17:45 |
| Holidays | 【有給休暇】有給休暇は入社後4ヶ月目から付与されます 初年度 12日 4か月目から 【休日】完全週休二日制 土 日 祝日 年末… |
| Industry | Pharmaceutical |
Job Category
- Electronics and Semiconductor Technology > Design, Development Engineer
- Machinery and Automobile Technology > Production, Factory Manager, QC (Machinery, Automobile)
- Medical, Pharmaceutical and Healthcare > Patent Specialist, Academic
