【焼津】Scientist, Drug Product Analytical Development, Analytical Research Labs at Astellas Pharma Inc.
On-siteYaizu, Shizuoka, Japan
Yaizu, Shizuoka, JapanOn-siteFull TimeDoctorate Or Professional DegreeEnterprise
Full TimeDoctorate Or Professional DegreeEnterprise
Job Summary
Conduct product characterization, develop test methods, and establish control strategies for IND/IMPD/CTD submissions while managing CMO/CRO relationships and external joint development partners. Prepare application documents, support regulatory interactions, and transfer analytical methods to testing sites. Improve work efficiency across all analytical activities and perform laboratory operations. This role requires moderate supervision and involves both office and laboratory work in Yaizu, with remote options available. Master's degree and three years of CMC analytical experience are required.
Required Qualifications
- Master's degree or higher (including a 6-year Pharm.D. program)
- At least 3 years of CMC analytical experience
- Solid understanding and knowledge of GMP and regulatory guidelines required for submissions, as well as a good understanding of analytical methods
- Hands-on experience with analytical techniques such as HPLC
- Strong communication skills
- Ability to communicate effectively with CROs and other partners located worldwide, with an understanding of cultural diversity
- English proficiency required for the role (TOEIC 730+)
Desired Qualifications
- At least 3 years experience of drug product analytical development for synthetic molecule
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