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.
■職種未経験者:不可