Lead, Microbiological 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.

勤務地：宮崎工場

＜職務概要＞

微生物検査及び無菌保証業務全般を監督・管理する。

無菌試験、バイオバーデン試験、エンドトキシン試験、環境モニタリング、滅菌器資格認定が主な業務範囲であり、微生物学的および無菌性保証に関連するバリデーションも含まれる。

＜主な職務内容＞

●品質要件を満たす作業に責任を持ち、責任ある作業を時間通りに実行する。

●グループ内の作業が手順を遵守していることを確認し、技術と記録の正確性を保つ。

●無菌性保証チームメンバーとして、製品の無菌性を保証する。

●微生物検査を実施し、日々の製造を保証する。

●責任ある作業で製造をサポートする。

●関連規制、GxP、Vantive 品質システム、適用される国際コンセンサスなどの遵守を確保する。

●作業に必要な設備を入手し、安全な環境を提供する。

●スタッフに必要なトレーニングを実施し、適切な人材配置を行う。

●必要なバリデーションや文書化を計画し、実施するために、他のグループや研究開発グループとの共同作業をサポートする。

●BOS業務を推進し、グループ内のスタッフを指導・サポートする。

●グループ内のスタッフを育成する。

●宮崎工場内外の利害関係者間の対立を解決する。

●規制、管理、IT業務の一部を遂行し、またはグループ内のスタッフに業務を割り当てる。

●ヴァンティブや他社の製品開発をサポートし、利益を得るための委託業務を行う。

●問題解決のためにラボメンバーを指導する。

●工場管理メンバーとして働く。

＜資格 / 学歴 / 経験＞

●微生物関連業務、品質管理、またはそれに準ずる業務経験数年以上。

●無菌性保証に関する知識。

●医薬品の責任、公式コンペンディウムの要求事項、PIC/S、ISO、ICH、その他の科学に関する知識。

●海外との意見交換が可能なビジネスレベルの英語力。

●医薬品医療機器等法、GMP、GQP、QMS、GLP、薬事許認可等、国内外規制に関する知識。

●テクニカルライティングのスキル。

●統計手法、リスク管理手法の知識。

●リーダーシップ

ーEnglish Followsーーーーーーーー

＜Role Overview＞

Manage Micro lab and in charge of sterility assurance in the facility

Responsible for microbiological tests and sterility assurance in the plant. Supervise and manage overall works of microbiological tests and as sterility assurance activities as lab leader. Sterility test, Bioburden test, Endotoxin test, environmental monitoring and sterilizer qualification are main scope area, included validations related microbiological and sterility assurance.

＜Key Responsibilities＞

• Be responsible for works to meet quality requirements and execute the responsible works on time.
• Make sure that works in the group comply with the procedures and keep the accuracy of techniques and records.
• Work as sterility assurance team member to assure sterility of products.
• Perform microbiological test to ensure the daily manufacturing.
• Support Manufacturing by the responsible works.
• Ensure compliance with related regulation, GxP, Vantive Quality System and applicable international consensus and so on.
• Obtain required equipment for working and provide safety environment.
• Execute necessary training for the staffs and perform proper assignment of human resources.
• Support collaboration work with other groups and R&D group in order to plan and implement required validations and documentation.
• Drive BOS works and, instruct and support the staff in the group.
• Develop the staff members in the group.
• Settle directly opposed interests between stakeholders of inside and out outside Miyazaki plant.
• Fulfill a part of regulatory, administrative and IT works, or assign the works to staffs in the group.
• Support product development for Vantive and other company, conduct consignment business to gain profit.
• Coaching lab members for problem solving.
• Work as one of plant management member.

＜Qualifications / Education / Experiences＞

• Work experience of microbiological related work, quality control or equivalent more than several years.
• Knowledge about sterility assurance.
• Knowledge about pharmaceutical related to the responsibilities, requirements in official compendium, PIC/S, ISO, ICH and other science.
• Command of English which is able to exchange opinions with persons overseas.
• Knowledge of internal and external regulation such as Pharmaceuticals and Medical Devices Law, GMP, GQP, QMS, GLP and Drug Approval and Licensing Procedures in Japan.
• Skill of technical writing.
• Knowledge of statistic methods and risk management methods.
• Leadership

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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