External Manufacturing Associate Manager

Job Details

<求人タイトル>

17667 External Manufacturing Associate Manager

<職務内容>

The role of this position is to select external contractors for development and production and to lead their management and coordination. This position will also be responsible for proposing and implementing measures to improve the efficiency, quality, and yield of regenerative cell medicine production. Specific responsibilities are as follows.
・Manage and oversee operations at Contract Manufacturing Organization (CMO) to ensure on-time quality product meeting quality, compliance, and regulatory
requirements.
・Responsible for the timely execution of Technology Transfer plans to CMO in
preparation for clinical trials and commercialization.
・Ability to build trust and garner positive relationships as Person in Plant at CMO.
・Establish and manage MSA, SOW, and other manufacturing agreements.
・Possess a thorough knowledge of Quality Management Systems. Ensure timely
closure of deviations, CAPA, and implementations at CMO.
・Effectively communicate changes and resolve issues with CMO.
・Proactively develop manage, track, and improve CMO performance. Set milestones and monitor KPIs. Report out CMO Manufacturing updates.
・Collaborate with Supply Chain to develop and monitor site budgets.
・Lead and/or participate in cross functional Technical Operations projects to ensure the company’s objectives.
・Other duties as assigned

<応募要件>

・Bachelor’s degree in Life Sciences or related field with a minimum of 5 years of
directly related GMP pharmaceutical manufacturing experience.
・Knowledge of pharmaceutical cell therapy processes.
-Direct GMP aseptic cell culture experience is a major plus.
・Languages: Fluent in both English and Japanese
・Technology Transfer experience required.
・Financial acumen is required for working with operational budgets and budget
planning.
・Ability to collaborate cross functionally in a function.
・Project Management experience is a plus.
・Ability to work independently and as part of a team.
・Ability to travel as needed. Approximately up to 25% travel.
・Candidates must be authorized to work in Japan.

<会社概要>

画期的な再生細胞薬の開発に力を入れているグローバルバイオ医薬品企業です。世界最先端の研究開発に全社員でチャレンジする企業風土です!

契約期間:期間の定めなし(定年 60 歳、その後 65 歳までの再雇用あり)
就業時間:9-18時(ただしフレックスタイム制度あり)

<注目ポイント>

最先端技術を持つ注目のグローバル企業から、生産管理ポジションのご紹介です!インターナショナルな環境で、ご自身の英語力も培っていただけます。ご興味がございましたら、是非お早目にお問い合わせください!

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