Sr Process Engineer
* Drive process and technology transfers, change management, and technical process support for cell therapy products at the CMO.
* Implement and support the execution of process control strategies including execution of process risk assessments, and continued process verification.
* Support production related investigations, ensuring compliance with internal standards and regulatory requirements
* Perform monitoring of manufacturing processes to understand process capability.
* Strong technical background (> 7 years of experience) in biologics manufacturing and or process development. Familiarity with cell therapy processes and analytical methods is a plus
* Expert knowledge of cGMP's and multi-national pharmaceutical regulations
* Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities (experience with cell therapy preferred)
* Hands-on experience with single-use technologies, closed systems, and cold chain technologies
* Experience working with external parties and/or leading cross-functional teams
* Project management experience leading multi-functional teams
* Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.
* Ability to prioritize and provide clear direction to team members in a highly dynamic environment
* Experience with Operational Excellence and Lean Manufacturing
* Proficiency utilizing MS Office products and knowledge of statistical software (R, JMP, Minitab)
* Fluency in Japanese and English language
Salary ; 8M.