エージェント取り扱い求人

グローバルワクチンビジネスユニット ワクチン生産技術G (原薬または製剤) 課長代理/担当者

募集中
  • 勤務地
    山口県
  • 職種
    その他製剤化/製造・生産関連職
  • 業種
    医薬品メーカー(先発医薬品)

募集要項

業務内容 GMPに関する知見を基に、新規ワクチンの商業生産化、そして既存ワクチンの更なる製造安定化と価値向上に資する業務を行っていただきます。

<新規ワクチンの商業生産化>

・ワクチン製造プロセス・設備に関する技術検討やバリデーションの立案・実行

<既存ワクチンの更なる製造安定化と価値向上>

・製造プロセス改良、有効期間延長、マテリアル変更に関する技術検討やバリデーション

・価値向上のための製品改良業務など

(例)・最新GMPに対して洗浄バリデーションプログラム(分析対象物質、洗浄方法、サンプリング箇所など)のアセスメントを行い、それを文書化する。分析対象物質を正しく評価できる手法を開発し、変更後の洗浄方法が妥当であることを示すデータを製造部門と連携して取得する。

・原材料や製造法の変更にあたり、変更が品質に与える影響を評価するために必要な情報を精査し、実験検討やバリデーションを立案する。ラボスケールや商用スケールで製品を試製してデータを取得し、変更が品質に与える影響を評価し、その変更を関連部門と連携して推進する。

・プロジェクトチームと連携し、グローバルスタンダードの生産設備や製造プロセスをデザインし、投資額やタイムラインを策定する。
雇用形態 正社員
応募資格 <学歴>

大学(薬学系、工学系、理学系、農学系、化学系または機械系)卒業以上、もしくは同等の知識・経験・スキルを有する方(高専可)

<実務経験>

【必須要件】

・プロトコルやSOPの作成と実行の経験

( 技術検討・バリデーションの計画書・報告書、手順書の作成など)

・医薬品製造のプロセスや設備に関するGMP基礎知識

【望ましい要件】

・無菌医薬品の開発または製造に関する知識・経験

・製造プロセスの技術検討・バリデーションや、洗浄・滅菌バリデーションに関する知識・経験

・ビジネスにおける英語使用経験

求める人物像

・誠実に、また自主的に物事に取り組める方

・チームワークおよびコミュニケーションを大切にできる方

本職務で身につくスキル・経験

・ワクチンや無菌医薬品開発の知識・スキルを広く身につけることができます。

・グローバルの専門家とのディスカッションを通じて、バイオ医薬品や無菌製剤のグローバルスタンダードを深く理解できます。

・技術面やビジネス面のリスク特定やソリューションの立案・実行を通じて、問題解決スキルやプロジェクトマネジメントスキルを身につけることができます。

仕事のやりがい

日本初のCOVID-19ワクチン製造は、やりがいのあるプロジェクトであるとともに、非常に高い社会貢献度および達成感を得ることが出来ます。
英語力 ビジネスレベル
年収 500万 〜 1300万円
給与詳細
月額(基本給):310,000円~
<昇給有無>有
<残業手当>有
<給与補足>
※年収は前職の経験を考慮の上、規定により決定します。
■昇給:原則年1回
■賞与:年2回
勤務地 山口県
備考 ”Better Health for People, Brighter Future for the World” is the purpose of a company.We aim to create a diverse and inclusiveorganization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transformthe lives of patients. We’re looking for like-minded professionals to join us.
global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of ism, whichhas been passed down since the company’s founding. ismincorporatesIntegrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.

企業情報

匿名

関連する求人

エージェント取り扱い求人
Lead, Plant Sustainability Engineering

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  • 600万〜1000万
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募集中

エージェント取り扱い求人
Project Controls Engineer(Associate Director), Japan New Plasma Facility Project

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  • 500万〜800万
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募集中

エージェント取り扱い求人
Commissioning & Qualification Lead, Japan New Plasma Facility Project

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  • 600万〜1000万
  • 大阪府
  • 医薬品メーカー(先発医薬品)

募集中

エージェント取り扱い求人
Commissioning & Qualification (CQ) Engineer, Japan New Plasma Facility Project

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  • 600万〜1000万
  • 大阪府
  • 医薬品メーカー(先発医薬品)

募集中