外部サプライAPI技術担当者/Principal Scientist or Senior Scientist API Oncology ESSM

求人会社名 : 武田薬品工業株式会社

求人ID : NJB2027088

  • エージェント取り扱い求人
  • 上場企業
  • 従業員1000名以上
  • 語学(英語)を生かす
  • 土日祝日休み
  • 年間休日120日以上
  • 設立50年以上

募集要項

仕事内容 This position will be the primary technical point of contact for the API SM OpU with external Contract Manufacturing Organizations. The primary role will be to provide scientific and technical expertise for all drug substance related activities ensuring that new and existing drug substance technology and related processes procedures and specifications are developed and transferred to our contract manufacturing operations (CMOs) in a manner compliant with all regulatory and quality standards and supports cost effective technical processes suitable for robust commercial production. Roles and responsibilities include but not limited to:

New product introduction and New Chemical Entity process validation
Technology selection and acquisition
Process design development optimization and verification
Technology transfer
Continuous improvement
Routine technical support
Develop and implement product technology strategies to ensure all API related business needs are met. Work closely with Pharm Sciences for the late stage product development to ensure seamless technology transfer to commercialization
Optimize manufacturing processes using robust DoE and QbD principles
Provide on site technical support at CMOs
Seek and Implement API improvement plans at CMOs
Ensure optimal utilization of manufacturing capacity
Investigate and address API process quality and compliance issues
Support inspections by the FDA and other government regulatory agencies
Write and review all regulatory documents (NDAs DMFs etc.)
Manage product risk by understanding potential product risks/vulnerability (technology safety compliance etc.) and proactively plan mitigation
Serve as a lead or member of Product Quality Technical Teams (PQTT). Participate in a cross functional team to provide technical expertise for all API related matters
Maintain and communicate project status and general issues to key stakeholders
Provide technical expertise in matters related to change control quality and r…
応募資格 Technical/Functional (Line) Expertise

Knowledge of the relevant cGMP ICH and global Regulatory CMC guidance documents applicable to the function. Keep current on all issues that will affect the use of APIs (Regulatory Stability QA and HSE).
In depth knowledge of Process Engineering Unit Operations and plant equipment.
In depth knowledge of QbD technology transfer process development scale up optimization DoE and PAT.
Demonstrated success in technical proficiency scientific creativity and independent judgment.
Able to serve as SME Author on CMC submissions. Support regulatory inspections and audits.
Leadership

Able to serve as an effective project team member and inspirational leader. In this capacity should be able to effectively communicate with cross functional team members as well as stake holders.
Be Positive Be Accountable Be Results Oriented and Be an Excellent Manager of Self and others.
Decision making and Autonomy

Understand market needs and key organizational priorities. Translate that understanding into meaningful business cases as necessary.
Provide effective API change control management and communicate decisions to all customers internal and external.
Work independently and make decisions quickly to support an agile organization
Interaction

Ability to interact develop credible relationships and communicate successfully with a broad spectrum of people including CMO’s Vendors / Suppliers and Colleagues.
Strong verbal and written technical communication skills.
On a routine basis interacts internally in person or remotely with individuals from Product Strategy Quality Compliance External Supply Management Pharm Sciences GMSci Regulatory Affairs and SM OpU.
Interacts externally in person or remotely with key Suppliers Contract Manufacturing Organizations Equipment Manufacturers Consultant Groups Regulators Scientific Experts etc.
Innovation

Continuous improvement experience and capable of applying multiple operational…
勤務地 大阪府
勤務時間 08:00 ~ 16:45
年収・給与 800万円 - 1200万円
待遇 【通勤手当】全額支給
【社会保険】健康保険
厚生年金
雇用保険
労災保険
【その他手当】住宅手当
休日・休暇 【有給休暇】12
【休日】完全週休二日制


祝日
休日:土曜、日曜、祝日、メーデー、年末年始など(年間123日程度)
休暇: 年次有給休暇、特別有給休暇、リフレッシュ休暇、産前産後休暇、育児休暇、子の看護休暇、介護休暇、フィランソロピー休職制度
雇用区分 無期雇用

求人会社概要

求人会社名 武田薬品工業株式会社
設立 9133
従業員数 5291人
概要 医薬品、医薬部外品等の製造・販売・輸出入
業種 食品・医薬品・化粧品

外部サプライAPI技術担当者/Principal Scientist or Senior Scientist API Oncology ESSM

この求人の取扱い紹介会社

株式会社 ジェイ エイ シー リクルートメント (東京/北関東/横浜/静岡/名古屋/京都/大阪/神戸/中国)

株式会社 ジェイ エイ シー リクルートメント(東京/北関東/横浜/静岡/名古屋/京都/大阪/神戸/中国)