Drug Development, Gene Therapy

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Description 【募集の背景 / Purpose & Scope】The primary purpose of the Scientist II, in Process Science, designs, evaluates and develops the suitable rAAV formulation to support the growing and diversifying portfolio of programs within AGT's pipeline. S/he is also responsible for product-related development, such as device compatibility, container-closure selection and tech transfer to GMP team. S/he partners with other internal stakeholders as required to identify new CMC technologies and assess external landscape for potential collaboration or other engagement. S/he collaborates with all team members and stakeholders to develop his/her own and their human and technical skills as well as to ensure activities are adequately proceeded and key milestones are achieved.アステラス製薬では遺伝子治療を研究開発戦略上のPrimary Focusの一つに位置付け、活動のCenter of ExcellenceとしてAstellas Gene Therapiesを設置し、患者さんへいち早く医療を届けるべく日々研究開発に邁進しています。Astellas Gene TherapyのCMC 研究ラボであるProcess Scienceでは、多くのポートフォリオを開発していくうえで非常に重要となる処方検討及び製剤関連技術の確立と強化に向け、複雑な構造と重要品質特性を理解し、積極的にそして協働的に活動に一緒に取り組んでいただく熱意のある研究者(Scientist II)を募集します。【職務の内容 / Essential Job Responsibilities】(雇入れ直後)

  • Develop suitable formulation for each serotype, including engineered capsids, with appropriate analytical tools
  • Conceive and conduct device compatibility for ensuring injected amounts
  • Evaluate and assess new container-closure for local injection products
  • Lead the technical discussion cross-functional/divisional to be aligned and enable to proceed with drug development works appropriately and efficiently
  • Evaluate and understand analytical tools and methods deeply enable to develop rAAV formulation appropriately
  • Create and evaluate novel and innovative technology applicable to drug development for AAV product
  • S/he participates the program meeting to achieve key milestones with timely manner
  • Regularly presents data and conclusions in sub-team meetings
  • Occasionally presents technology summaries to management and program teams(変更の範囲) 会社内での全ての業務【就業環境に関する要件 / Specific Physical or Environmental Requirements】On-site (Tsukuba in Japan)【応募要件 / Qualifications】
  • Advanced degree in biology or engineering with 8+ years of relevant biopharmaceutical industry experience
  • Experience of formulation development and/or drug product development for biopharmaceutical products
  • Experience working with external vendors, institutions, and other collaborators to develop and/or evaluate new and disruptive technologies
  • Experience operation of basic analytical tools, such as chromatography and electrophoresis
  • Proven and successful history of taking direction and work independently in a fast paced environment
  • Positive, professional attitude with a passion for science
  • Outstanding collaboration, problem solving team player with excellent communication and organizational skills
  • Business English level
  • Prior rAAV gene therapy vector or other viral particle experience
  • Prior fill-finish experience
  • Experience with authoring IND, CTA, and other related regulatory filings and responding to Agency feedback/inquiries
  • Experience with tech transfer into GMP facilities/labs

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