Register Here to Apply for Jobs or Post Jobs. X

Analytical Development Research Scientist, Cell Therapy

Job in Fuji - Japan
Note that applications are not being accepted from your jurisdiction for this job currently via this jobsite. Candidate preferences are the decision of the Employer or Recruiting Agent, and are controlled by them alone.
For jobs on this site that accept applications from your location / country,
Company: Baxalta
Full Time position
Listed on 2019-11-02
Job specializations:
  • Pharmaceutical
    Pharmaceutical Production, Pharmaceutical Quality Assurance
  • Quality Control
    Quality Assurance, Quality Manager
Job Description & How to Apply Below
ACCOUNTABILITIES :
  • Develop analytical methods to characterize our cell products with several analytical techniques for incoming component/raw material inspection/testing, in-process testing, product QC testing and product deep characterization to support releasing of cell therapy drug product to clinical trial.
  • Execute analytical method transfer to contract manufacturing organizations and/or contract testing laboratories on product QC testing and product deep characterization for the IMP manufactured at Takeda facility and/or contract manufacturing organization.
  • Execute and/or manage analytical method validation for the IMP release test at Takeda facility and/or contract testing laboratories.
  • Manage stability studies at contract manufacturing organizations and/or contract testing laboratories.
  • Actively participate in problem identification, problem solving, and change initiatives in cooperation with other teams and functions.
  • Supports local and global initiatives which may include leading initiatives or work streams.
  • Assists with development of project strategy and communicates complex data/decisions within department and cross functionally as necessary.
  • Builds and maintains relationships with key vendors and assists with technical aspects of vendor negotiations
  • Understands project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional and external stakeholders.
  • Additional duties as assigned.
  • 武田が製造する細胞医療製品を臨床試験へ提供するために、原材料の受け入れ試験、工程管理試験、製品の品質管理試験、および製品の特性解析のための分析方法の開発及び制定。
  • 武田が製造する治験製品について、製品の品質管理試験、および製品の特性解析用の分析方法の、受託製造機関または受託試験機関への技術移管。
  • 武田が製造する治験製品についての分析法バリデーションを通じ、治験製品の品質管理試験の検証。
  • 受託製造機関や受託試験機関で実施する安定性試験の管理。
  • チームや他部署と協力し、問題の特定、問題の解決、および変革のイニシアチブへの積極的な参加。
  • 先導的な取り組みや作業の流れを含む、ローカルおよびグローバルな取り組みのサポート。
  • 部門内または部門横断的に得られたデータを交換・議論し、プロジェクトの戦略の策定の支援。
  • 主要ベンダーとの関係を構築し維持し、ベンダー交渉の技術的側面の支援。
  • プロジェクトのタイムラインと成果物を理解し、部門内・部門横断的に、外部の関係者とプロジェクトを運営。
  • その他、追加の職務。
  • EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • ExperiencesStrong analytical knowledge and techniques, and practical experience with analytical methods for cell therapy field (e.g. cell based-potency assay, flow cytometry, cell count, q-PCR, etc.) and advanced experience in at least one technique.Able to work in a lab setting.Bachelor’s Degree in Cell Biology, Biology or another relevant field. Masters preferred.CMC experience; More than three-year experience in analytical methods development, validation and transfer for biologics products and cell therapy products preferred.Experience with writing and reviewing SOP’s for analytical development function preferred.
  • SkillsAnalytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems, and determine causes and possible solutionsTeamwork -- Ability to work well in highly cross functional team environment and across global line functions.Communication Skills -Able to express one’s self clearly and concisely within a team; document issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates issues to supervisor; technical writing skills to support authoring of internal technical documents.Organization – Exercises good time management and prioritization skills and can successfully manage multiple tasks simultaneously Knowledge Sharing - Ability to capture organizational knowledge; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use.
  • 経験細胞医療製品に適用する分析方法(例えば、細胞ベースの効力アッセイ、フローサイトメトリー、細胞数、q-PCRなど)に関する、分析的知識および技術や実際的経験、並びに少なくとも1つの技術における高度な経験。実験室での作業が可能。細胞生物学、生物学、またはその他の関連分野の修士号以上が望ましい。CMCでの経験:3年以上CMC業務(バイオロジクス及び細胞医療製品)に従事しており、分析法の開発、バリデーション、技術移管の経験があれば望ましい。分析法開発業務に関連する作業手順書の作成及びレビューの経験があることが望ましい。
  • スキル分析および問題解決:重大な問題のトラブルシューティングを行い、原因と考えられる解決策を特定できるスキル。チームワーク:部門外またはグローバルな環境下でもうまく機能できるスキル。コミュニケーション:チーム内で自分自身を明確かつ簡潔に表現したり、問題や懸念を同僚に簡潔に説明したりするスキルに加え、相手に合わせてコミュニケーションスタイルを変化させ、タイムリーかつ効果的に問題をラインマネージャーに伝えるスキル。また、社内の技術文書の作成者をサポートするためのテクニカルライティングスキル。組織:適切な時間管理と優先順位付けをし、同時に複数のタスクをうまく管理するスキル。知識共有:組織の知識を把握し、その情報を利用して、方法、プロセス、成果物を改善していくスキル。
  • Locations

    Fujisawa, Japan

    Worker Type

    Employee

    Worker Sub-Type

    Regular

    Time Type

    Full time

    Apply Now Email Me
    Position Requirements
    Less than 1 Year work experience
    Note that applications are not being accepted from your jurisdiction for this job currently via this jobsite. Candidate preferences are the decision of the Employer or Recruiting Agent, and are controlled by them alone.
    For jobs on this site that accept applications from your location / country,
    Search for further Jobs Here:
    (Enter less keywords for more results. Suggestions may be selected)
    Location
    Employment Category
    Education (minimum level)
    Filters
    Education Level
    Experience Level (years)
    Posted in last:
    LOGIN Area - Jobsite