Job Information
Boehringer Ingelheim Formulation Development Expert | Staff or Non-Line Manager | Pharmaceutical Research Gr., CMC, KPRI in Kobe, Japan
Basic Purpose of the job
This position is responsible for technical and managerial leadership in developing state of the art solid oral formulations and robust manufacturing processes for mutiple complex projects in collaboration and coordination with internal and external partners.
Accountabilities
Develop solid oral formulations and manufacturing process for multiple complex NCE projects
Related Performance Indicators
'-Lead development of new formulations and robust manufacturing process for NCE projects
-Closely cooperate with Analytical Sciences to ensure quality of drug products developed
Author key documents of quality sections for global submissions
Related Performance Indicators
'-Prepare submission documents for NDA and CTA
-Interact with Regulatory Affairs and CMC Experts internally as well as regulatory authorities externally to obtain approvals on MAA and CTA
Manufacture clinical supply bulk for clinical trials by transfer of know-how
Related Performance Indicators
'-Develop manufacturing specifications for clinical supplies
-Transfer clinical bulk manufacturing to internal and external partners
Represent the discipline as Team Member of Pharmaceutics on international R&D Teams
Related Performance Indicators
'-Summarize all results, present all relevant data to the international R&D Team and prepares decisions
-Communicate and implement all team decisions within the department (matrix management function)
-Communicate and resolve conflict
-Leading the Formulation Subteam in Drug&Device Deliverable Team
Organize and supervise the technology transfer to receiving sites
Related Performance Indicators
'-Plan, prepare and conduct technology transfers meeting requirements
- Prepare documentations required for the transfer
Maximize the efficiency and motivation of the formulation subteam
Related Performance Indicators
'-Allocate tasks to team members properly
-Lead the formulation subteam globally and locally to maximize speed of formuation development with optimal laboratory resources
Promote internal and external innovations
Related Performance Indicators
'-Scout external new technologies/ideas to provide values to pipeline projects
-Encourage and promote internal innovations
Requirements:
-Extensive knowledge of formulation and manufacturing process development for solid oral dosage forms
- More than 7 years of experience in an international pharmaceutical R&D organization
-Sufficient CMC background with proven performance record (not less than 3 cross-functional projects)
-Undestanding of relevant global regulatory guidelines and submission/approval requirements (in particular FDA, EMEA, PMDA)
- PhD in science
-Excellent oral and written presentation skills in English
-International work experience (cross-cultural competence)
Recruiter : Suzuki
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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