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[Innovative Medicine] CAR－T Cell Collection Supervisor, CAR－T Regional Supply Chain, Manufacturing and Supply Div.
年収：800万 ～ 1100万
採用企業案件
ヤンセンファーマ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
| 部署・役職名 | [Innovative Medicine] CAR－T Cell Collection Supervisor, CAR－T Regional Supply Chain, Manufacturing and Supply Div. |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. We are hiring for a CAR-T Cell Collection Technician/Supervisor to be located in Japan and reporting to the manager in APAC region. Summary: CAR-T commercial supply chain technician/supervisor is responsible to manage the contracts and communication with third party suppliers including the hospitals and cellular cryopreservation sites in APAC countries. This individual will support the establishment and implementation for apheresis and cryopreservation operations. The Cell Collection Technician/Supervisor will support together with local staff to support international staff training and qualifications to perform cell collection and cryopreservation and also support performing and concluding technical investigations into apheresis starting material deviations. Harmonizes internal stakeholder requirements with external stakeholder level of comprehension and performance level to deliver a fit for purpose tech transfer and implementation experience for the stakeholder. This role fully accountable to establish third party for the successful product deliver in Asia Pacific with a peak market size of 2,000 patients. Able to combine operational efficiency and speed with compliance. |
| 応募資格 |
【必須（MUST）】 ■Responsibilities:Leads contracting, meetings with suppliers, and issuance of Purchase Orders (PO), Support fit for purpose technical transfer for FACT/JACIE compliant commercial apheresis and cryopreservation of leukapheresis starting material. Perform tasks on time consistent with the safety policies, quality systems and FACT/JACIE and/or other regulatory compliant requirements. Ensures seamless flow of knowledge and information across commercial and manufacturing functions, as well as, with hospitals as suppliers Maintain site readiness and compliance by maintaining change controls and actively supporting regulatory inspections as necessary. Possibility of managing a line and/or matrix teams of 5-10 indirect reports Develop a cohesive internal stakeholder team (e.g. External Quality, Procurement and Subject Matter Experts) Develop working relationship with international delegates receiving the technical method transfer. Coordinate and assist with external site audits for apheresis and cell labs, support and/or develop SOP, and training for technicians/nurses as needed. Facilitates near-real-time apheresis and/or cryopreservation quality investigation when required. Deliver site-specific education and answers on-demand questions related to leukapheresis and cryopreservation. Coordinate Information Technology, Logistic transport and regulatory requirements affecting apheresis material and cryopreservation activities. Develop and monitor site performance metrics. ■Qualifications: A bachelor’s degree in a scientific or engineering discipline is required. Project Management experience required. Ability to work independently and in a matrixed team environment is required. In addition to Japanese, fluency in English is required. Contracting and third-party management experience is preferred. First-hand experience in cryopreserving either fresh apheresis material, isolated cell populations or plasma/whole blood preferred. Extensive experience in successful tech transfers of complex lab processes is preferred. First-hand experience with cryopreservation methods for human mononuclear cells is preferred. 4 years of wet-lab research and development or cell processing laboratory experience is preferred. Experience being accountable to perform work following GTP, cGMP or GCP is preferred. Experience in writing, reviewing and implementing procedural and compliant documents is required. Working knowledge of JACIE or FACT immune effector cell handling requirements is required. Listening and communicating with cultural awareness, empathy and relatability Understanding of drug development and submission requirements is preferred. Manufacturing and logistics understanding/experience is preferred. Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Ability to lift a minimum of 25 lbs. and to stand for a long period of time are required. Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution is required. Work hours may require accommodation of up to a 17-hour time-zone difference with cryopreservation laboratory teams. |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2025/12/11 |
| 求人番号 | 6318669 |
採用企業情報
- ヤンセンファーマ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
-
会社概要
私たちヤンセンファーマは、世界最大級のトータル・ヘルスケア・カンパニー、
ジョンソン・エンド・ジョンソン（J＆J）グループの製薬会社として、いまだ
満たされていない医療ニーズに迅速に応え、最先端の医薬品を一刻も早く患者
さんの手元に届けることができるよう取り組んでいます。
私たちは、世界57ケ国200社以上に及ぶJ＆Jグループを貫く経営理念「我が信条
（Our Credo）」を志とし、さらに、46年間に84品目もの新薬を開発したヤンセ
ン・ファーマスーティカ社の創業者、ポール・ヤンセン博士の妥協なき開発精
神を継承し、J＆Jグループの優れた新薬の導入はもちろん、医療現場への適切
かつ最新の医療情報の提供、さらには、患者さんのＱＯＬ（クオリティ・オブ・
ライフ）の向上を目指した支援活動などをおこなっています。
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です