募集要項
- 募集背景
- We are seeking a highly skilled and motivated Plasma Manufacturing Process Scientist to join our team. As a Process Scientist, you will play a crucial role in the successful tech transfer of plasma processes and products to our new plasma facility in Japan. Reporting to the Head of Manufacturing Science, you will be responsible for driving process validation strategies and ensuring the robustness and reliability of our manufacturing processes.
- 仕事内容
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[Responsibilities]
1. Collaborate closely with pharma science, regulatory, and quality control organizations, as well as process experts across our global plasma network.
2. Provide leadership and guidance to team members, assisting them in prioritization, problem resolution, and process clarification.
3. Direct the effective transfer of technology from design development to implementation.
4. Evaluate the suitability of new technologies for implementation and transition to the manufacturing floor.
5. Ensure successful product technical transfer to the new plasma facility.
6. Establish reliable yield status and accurate yield forecasts for all transferred products, implementing strategies to meet yield targets.
7. Develop and direct strategies for yield improvement projects, lead time reduction, process security, and deviation reduction.
8. Assure process robustness and supply reliability by controlling the manufacturing process life cycle.
- 応募資格
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- 必須
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1. Bachelor's degree in a science-related field required; Master's or PhD degree in a technical/scientific education, preferably biochemistry, biotechnology, or pharma, is preferred.
2. At least 5 years of professional experience in a similar role in the field of Technical Operations, Process Management, or Manufacturing within the pharmaceutical industry, with significant experience in fractionation, purification, and fill-finish processes.
3. Excellent verbal, written, and interpersonal communication skills in English and Japanese.
4. Ability to build relationships, influence, and drive organizational engagement in a highly matrixed, cross-functional, and geographically dispersed environment.
5. Strong knowledge and application of GMPs, FDA, EMA, PMDA, Lean, Six Sigma, and DMAIC methods.
- 雇用形態
- 正社員
- 勤務地
- 大阪府
- 勤務時間
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勤務時間：本社（大阪市中央区・東京都中央区）9:00～17:30 、
工場（山口県光市・大阪市淀川区）8:00～16:45 、（千葉県成田市）8:45～17:15 、
研究所（神奈川県藤沢市）9:00～17:45
フレックスタイム制、テレワーク勤務制あり（対象社員）
- 年収・給与
- 年俸1200万円 ～ 1700万円
- 待遇・福利厚生
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諸手当：通勤交通費、借家補助費、勤務時間外手当など
健康保険・厚生年金・労災保険・雇用保険
昇給：原則年1回
賞与: 原則年2回
- 休日休暇
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土曜、日曜、祝日、メーデー、年末年始など（年間123日程度）
休暇：年次有給休暇、特別有給休暇、傷病休暇、ファミリーサポート休暇、産前産後休暇、育児休暇、子の看護休暇、介護休暇
- 選考プロセス
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書類選考
1次面接
Webの適正テスト
2次面接
