Supervisor, Chemical Lab

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Main Responsibilities

• Perform the following duties in accordance with the scope of responsibility.
• Strictly follow the Vantive Quality Policy and relevant regulations and guidelines.
• After understanding analytical techniques and principles through education complete the tests strictly on time.
• The following chemical tests and particulate matter tests are carried out and data is managed.

　　Main – Bioscience test　:　Requested tests, Bioscience lab control

　　Sub －Chemical lab test　: Followings

　　Raw materials (drug substances, additives, etc.) receiving tests

　　Initial test for each mixed solution after mixing preparation (late-night work: allowance available)

　　In-process testing

　　Final product testing (including insoluble substance testing)

　　Imported product testing (including insoluble substance testing)

　　Stability testing/monitoring

　　Plastic container testing

• Conduct tests in accordance with work standards, enter or review results using prescribed forms, confirm test results, and faithfully comply with quality requirements.
• Investigations and CAPA activities are carried out when OOS (ouf-of-specification) /in-valid occurs.
• Carry out maintenance activities to avoid equipment problems and resolve problems when problems occur.
• Schedule and perform equipment calibrations, regular inspections.
• Purchase reagents, standard products, and consumables based on current inventory and expiration dates.
• Participate in activities such as improvements and efficiency improvements within the factory.

主な業務内容

責任範囲に応じて、以下の職務を遂行する。

●Vantive Quality Policy および関連する規制およびガイドラインに厳密に従う。

●教育を通じて分析技術と原理を理解した後、時間厳守でテストを完了する。

●以下の化学試験、粒子状物質試験を実施し、データを管理する。

　メイン – バイオサイエンス試験 : 依頼された試験、バイオサイエンスラボ制御

　サブ　–　ケミカルラボテスト : 以下試験を受ける原材料(原薬、添加物など)

　混合調製後の各混合溶液の初期試験(深夜作業:手当あり)

　インプロセステスト

　最終製品試験(不溶性物質試験を含む)

　輸入品試験(不溶性物質試験を含む)

　安定性試験/モニタリング

　プラスチック容器試験

●作業基準に則った試験を実施し、所定の様式を用いて結果を入力または審査し、試験結果を確認し、品質要求事項を忠実に遵守する。

● 調査と CAPA 活動は、OOS (ouf-of-specification) /in-valid が発生した場合に実行される。

● 設備トラブルの回避とトラブル発生時の問題解決のためのメンテナンスを行う。

●機器の校正、定期点検をスケジュールして実行する。

●試薬、標準製品、消耗品は、現在の在庫と有効期限に基づいて購入する。

●工場内の改善や効率化などの活動に参加する。

Qualification / Education / Experience

• Keep good relationship between contracted companies.
• At least 2years of quality tests experience in Biochemical area.
• At least 3years management / Lab control experience in lab.
• Knowledge about pharmaceutical manufacturing and quality testing
• Chemical tests in Japanese Pharmacopoeia.
• Bachelor's degree
• PC skill (at least MS-Word, Excel)
• Knowledge of GMP, Risk management, Data integrity and statistics is preferable.
• Japanese Native, English skill is preferable.

資格・学歴・経験

• 契約ベンダーとの良好な関係を保てること。
• 生化学分野での少なくとも2年間の品質試験の経験。
• ラボでの3年以上の管理/ラボ制御の経験。
• 医薬品製造と品質試験に関する知識
• 日本薬局方での化学試験経験。
• 学士号
• PCスキル(MS-Word、Excel以上)
• GMP、リスク管理、データの完全性、統計に関する知識があると望ましい。
• 日本語ネイティブ、英語力があれば望ましい。

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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