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開発企画
| Hiring Company | 非公開 |
| Location | Tokyo - 23 Wards |
| Job Type | Permanent Full-time |
| Salary | 4.5 million yen ~ 6.5 million yen |
Job Description
【求人No NJB2321447】
■職務内容
CMC担当者として、当社製品の開発に関するCMC戦略の立案及び承認申請業務。
・製造及び試験手順の理解に基づくCTD作成（主にCMC）、及び照会対応
・海外の関係会社/研究機関との協業における資料提出期限や品質の確保
・海外の関係会社/研究機関とのコミュニケーション（医薬品の海外導出）
・DMFの作成、変更対応
General Requirements
| Minimum Experience Level | No experience |
| Career Level | Mid Career |
| Minimum English Level | Business Level |
| Minimum Japanese Level | Native |
| Minimum Education Level | Bachelor's Degree |
| Visa Status | Permission to work in Japan required |
Required Skills
【必須】
医薬品開発におけるＣＭＣ業務の経験
【歓迎】
・生物学、微生物学、薬学履修者、薬機法に関する知識
・医薬品のグローバル開発又は海外導出経験
・注射剤、点眼剤等の無菌製剤の経験
・研究所/工場における原薬/製剤開発、品質管理の経験
Job Location
- Tokyo - 23 Wards
Work Conditions
| Job Type | Permanent Full-time |
| Salary | 4.5 million yen ~ 6.5 million yen |
| Work Hours | 08:50 ～ 17:30 |
| Holidays | 【有給休暇】10日～20日（下限日数は入社半年経過後の付与日数となります） ＊詳細はオファー時に提示いたします 【休日】完全週… |
| Industry | Pharmaceutical |
