Associate Director, RA CMC

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。

Position Summary:

The position is responsible for all the operational matters related to RA CMC activities in designated project under the supervision of the Head of RA CMC Japan. As the nature of Genmab KK start-up phase, this position covers not only RA CMC-related activities but also helps support various operational matters for Regulatory Affairs & QA functions.

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

Respond to Health Authorities' inquiries interacting with global colleagues.

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.

• More than a bachelor's degree, a pharmacist license is preferable.
• At least 5 years of pharmaceutical industry experience in RA CMC, either in RA and/or QA.
• At least 3 years of bio/synthesis/analytical/formulation laboratory and/or manufacturing experience.
• Experience in preparing M1.2 and 2.3 (biological products) based on Global M3, Batch record, SOP, Validation report, and Stability report.
• English (business level)