Senior Manager/Manager RA CMC, RA CMC

1日前

Tokyo - Midtown Tower Genmab

ジェンマブは革新的な抗体医薬の開発に注力し、患者さんの生活を改善することに力を尽くしています。

私たちは、extra[not]ordinary な未来を共に築くことを使命とし、革新的な抗体製品の開発や人々を感動させる抗体医薬品で、がんやその他の深刻な病に苦しむ患者さんの生活を根本的に変え、治療の未来を切り拓いています。

ジェンマブは思いやりがあり、率直で、患者さんに貢献したいという強い思いを持った人たちがともに働き、科学に基づく変化をもたらします。大胆さと高潔性を持って行動し、新しい未来をつくることを目指すこと が、この使命を果たすために不可欠だと信じています。

私たちは大きな志を掲げ、楽しく、そして思いやりの心を忘れずに、日々意義のある仕事に取り組んでいます。私たちは、個々のユニークな貢献を受け入れ、それらを原動力として、患者、ケアパートナー、ご家族、そして社員のニーズを満たす革新的なソリューションを生み出し、育み、維持するグローバルな企業文化の構築に努めています。

私たちの想いに共鳴し、自分らしく活躍できそうだと感じたら、ぜひ一緒に働きましょう。

Responsibilities will include, but are not limited to;

Make a strategic J-NDA plan for RA CMC and execute;

Deeply understand CMC requirements for J-NDA, especially for small molecules and/or biological products and evaluate the global CTD and conduct gap analysis.

Plan & execute CMC-related CTD preparation collaborating with QA and RA colleagues to keep J-NDA timeline.

Decide J-CTD (m3) policy related to CMC, draft J-CTD with global colleagues, and realize high-quality J-CTD.

Draft J-CTD (m2.3) based on J-CTD (m3), independently (for Senior Manager)/ under Senior or Group Manager supports (for Manager)

Explore appropriate strategic options and respond to Health Authorities' inquiries interacting with global colleagues in consideration of approval matter.

Select and manage 3rd  vendors related to CMC in order to ensure robust CMC activities.

Support & execute QA/RA activities if required.

Execute post-approval lifecycle management;

Evaluate the changes/deviations of manufacturing/analytical procedure which may affect approval matters for MCN/PCA.

Plan the MCN/PCA schedule and share it with QA/RA/global colleagues. Lead regulatory activity related to the change.

Manage appropriate CTD lifecycle and ensure the consistency between Master Batch Record/SOP, CTD (m3 and m2.3) and approval matter (m1.2).

Grasp the latest domestic and overseas technologies and regulations;

Strive for self-improvement through industrial seminar and activities and always maintain the latest knowledge.

Implement/Use the acquired knowledge and information (trends of other companies etc.) in business.Depth understanding of Manufacturing/Testing methods, prepare high-quality CTD;

Understand the details of the actual manufacturing process and analytical procedures and create a CTD that is consistent with batch records and SOPs.

Be involved in project team meetings;

Understand the background of the product/formulation development and grasp its development schedule.

Sharing information with global teams when there are RA CMC-related requirements specific to Japan.

Mentor and/or Support the other members (for Senior manager only);

From the regulatory CMC perspective, give advice/support/mentor to the other members.

Requirements

  • More than a bachelor's degree, a pharmacist license is preferable.
  • At least 5 years of pharmaceutical industry experience in RA CMC.
  • At least 5 years of bio/synthesis/analytical/formulation laboratory and/or manufacturing experience.
  • Experience in preparing M1.2 and 2.3 (small molecules and/or biological products) based on Global M3, Batch record, SOP, Validation report, and Stability report.
  • English (business level).
  • Compliance and integrity; think about own action and take responsibility.
  • Passion to develop & get approval for Genmab's innovative products.
  • Goal oriented.
  • Strong curiosity for life science & regulations.
  • Work as one team and respect each other.
  • Executions with strategies, attention to details

場所

ジェンマブは、可能な限り柔軟な働き方を取り入れることで、社員のワークライフバランスの向上に取り組んでいます。

私たちのオフィスは、オープンな環境の中で従業員同士がつながることを目的としています。オフィスでも、リモートワークでも、お互いにつながることを大切にし、イノベーションを生み出します。

 ジェンマブについて

ジェンマブは、革新的抗体医薬を通じて患者さんの生活を向上させることを目指す、グローバルバイオテクノロジー企業です。

25年間、情熱的で革新的、そして協力的なチームが、次世代抗体技術プラットフォームを開発し、トランスレーショナルサイエンス、定量科学、データサイエンスを活用することで、独自のパイプラインを確立してきました。このパイプラインには、二重特異性T細胞エンゲージャー(bispecific T-cell engagers)、抗体薬物複合体(ADC)、次世代免疫チェックポイントモジュレーター、エフェクター機能強化抗体などが含まれています。

ジェンマブのビジョンは、2030年までに、人々を感動させる抗体医薬品でがんやその他の深刻な病に苦しむ患者さんの生活を根本的に変えることです。

ジェンマブは、1999年に設立されたデンマーク・コペンハーンに本社を構え、北米、ヨーロッパ、アジア太平洋地域に国際的な拠点を展開しています。

ジェンマブでは、候補者個人データ及びプライバシーを重要なものと認識しており、個人情報の保護に関する法律その他の関係法令を遵守しています。個人情報の取扱いにご同意いただいた上、ご応募ください。

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