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 dont 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.
• Bachelors 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-WordExcel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

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams where fraudulent parties pose as Vantive employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself review our Recruitment Fraud Notice.