Associate Scientific Fellow, Downstream Technology Transfer Lead, Drug Substance Operations, Biotherapeutics Process Development, Pharmaceutical Sciences

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Job Description

Associate Scientific Fellow, Downstream Technology Transfer Lead, Drug Substance Operations, Biotherapeutics Process Development, Pharmaceutical Sciences

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Workday「職務内容」（社内・社外共通）

Please note this job requires native-level Japanese language command not only in speaking, business writing and reading, as well as strong English communication skills to collaborate effectively and lead discussions in a global organization.

タケダの紹介

タケダでは常に患者さんを中心に考え、世界中の人々により健やかで輝かしい未来をお届けすることを目指してきました。そして従業員一人ひとりにそれぞれの能力と熱意に応じた成長の機会を提供することにも取り組んでいます。私たちと一緒に、世界中の人々のいのちに貢献し、さらなる成長と活躍を目指しませんか。

タケダは業界を牽引するグローバルリーダーです。従業員は四つの優先順位（患者さん中心、社会との信頼関係構築、レピュテーションの向上、事業の発展）とタケダイズム（誠実＝公正・正直・不屈）のもと一致団結しています。タケダイズムは私たちの信念であり正しい方向へ導く羅針盤です。私たちは日々の業務においてタケダイズムを体現しています。

Takeda is unwavering in our commitment to patients. With the patient at the center of everything we do, we continue to innovate and drive changes that will better their lives — we are looking for like-minded professionals to join us.

Takeda is a global industry leader. We are united by our four priorities (Patients, Trust, Reputation, and Business) and our shared values of Takeda-ism: Integrity, Fairness, Honesty, and Perseverance. Takeda-ism is more than just a word. It is a belief and a mindset which guides our decisions, behaviors, and interactions. It is how we strive to work and live, every day.

募集部門の紹介

Pharmaceutical Sciences（PS）は、タケダの研究開発（R&D）部門において、CMC、分析科学、製剤開発、プロセス開発、技術移管、および治験薬供給を担うグローバル組織です。革新的な医薬品を患者さんに届けるため、初期開発から治験薬供給、規制対応、商業化に向けた技術基盤の構築まで、科学的および技術的な観点から研究開発を支えています。

Biotherapeutics Process Development（BPD）は、バイオ医薬品原薬のプロセス開発、スケールアップ、および治験薬製造支援を担うグローバル組織です。BPDは米国および日本のサイトで構成され、プロセス開発、工程内分析、技術移管、治験薬製造支援、および分析開発の専門性を結集し、初期開発から治験薬供給、規制対応まで一貫してバイオ医薬品開発を推進しています。

Downstream Technology Transfer Leadは、Drug Substance Operations内において、精製プロセスに関するTechnology Transfer、GMP manufacturing readiness、およびsite transfer executionを科学的・技術的に支援するAssociate Scientific Fellowレベルの役割です。本ポジションは、Global Downstream Process Development、Drug Substance Operations、Early In-Process Analytics、Analytical Development、Quality、Manufacturing、およびGMP Facility Managementと密接に連携し、開発されたdownstream process knowledgeをGMP製造における実行可能な計画および移管成果へつなげます。

Pharmaceutical Sciences (PS) is a global organization within Takeda Research & Development responsible for CMC, analytical sciences, pharmaceutical development, process development, technical transfer, and clinical supply. PS provides the scientific and technical foundation required to advance innovative medicines from early development through clinical supply, regulatory support, and commercialization readiness.

Biotherapeutics Process Development (BPD) is a global organization responsible for biologics drug substance process development, scale-up, and clinical manufacturing support across development stages. Operating across sites in the United States and Japan, BPD brings together expertise in process development, in-process analytics, technical transfer, clinical manufacturing support, and analytical development to advance innovative biologic medicines from early development through clinical supply and regulatory support.

The Downstream Technology Transfer Lead is an Associate Scientific Fellow-level role within Drug Substance Operations responsible for providing scientific and technical leadership for downstream technology transfer, GMP manufacturing readiness, and site transfer execution. The role works closely with Global Downstream Process Development, Drug Substance Operations, Early In-Process Analytics, Analytical Development, Quality, Manufacturing, and GMP Facility Management to translate downstream process knowledge into executable GMP manufacturing plans and successful transfer outcomes.

職務内容

• Provide ASF-level scientific and technical leadership for downstream technology transfer activities within Drug Substance Operations.

• Lead technical assessment of downstream transfer packages, including process descriptions, critical process parameters, control strategy, scale-up assumptions, and manufacturing readiness.

• Support internal technology transfer from process development to GMP manufacturing execution and site implementation.

• Provide technical guidance for downstream GMP manufacturing preparation, campaign execution, deviation investigation, troubleshooting, and process improvement.

• Partner with Global Downstream Process Development to align process understanding, technical assumptions, transfer expectations, and risk mitigation plans.

• Collaborate with Early IPA, Analytical Development, Quality, Manufacturing, and GMP Facility Management to enable integrated transfer execution.

• Identify and mitigate technical risks related to downstream process robustness, manufacturability, site implementation, and GMP facility readiness.

• Provide scientific input to manufacturing readiness reviews, process implementation plans, batch documentation, and campaign preparation.

• Mentor scientists and engineers in downstream technology transfer, GMP execution, scientific problem solving, and technical decision-making.

• Drug Substance Operationsにおけるdownstream technology transfer活動に対し、ASFレベルの科学的・技術的リーダーシップを提供する。

• プロセス記述、Critical Process Parameters、Control Strategy、スケールアップ前提、およびmanufacturing readinessを含むdownstream transfer packageの技術的評価をリードする。

• プロセス開発からGMP製造実行およびsite implementationへのinternal technology transferを支援する。

• downstream GMP製造準備、製造キャンペーン実行、Deviation investigation、トラブルシューティング、およびプロセス改善に関する技術的助言を提供する。

• Global Downstream Process Developmentと連携し、プロセス理解、技術的前提、移管期待値、およびリスク低減策を整合させる。

• Early IPA、Analytical Development、Quality、Manufacturing、およびGMP Facility Managementと連携し、統合的な移管実行を支援する。

• downstream process robustness、manufacturability、site implementation、およびGMP facility readinessに関する技術リスクを特定し、低減する。

• Manufacturing readiness review、process implementation plan、batch documentation、およびcampaign preparationに科学的インプットを提供する。

• downstream technology transfer、GMP execution、科学的問題解決、および技術的意思決定に関してscientistおよびengineerを指導・育成する。

応募要件

＜学歴＞

• Bachelor’s or Master’s degree in biotechnology, biochemical engineering, biochemistry, chemical engineering, pharmaceutical sciences, or related field required. PhD preferred. Significant relevant industry experience in biologics downstream process development, technology transfer, GMP manufacturing, or manufacturing technical support is required.

• バイオテクノロジー、生物化学工学、生化学、化学工学、製薬科学、または関連分野における学士号または修士号を有すること。博士号（PhD）を有していれば尚可。加えて、バイオ医薬品のdownstream process development、technology transfer、GMP manufacturing、またはmanufacturing technical supportにおける十分な実務経験を有すること。

＜実務経験＞

• Ten or more years of experience in biologics downstream process development, GMP manufacturing, technology transfer, or manufacturing technical support.

• Demonstrated experience leading downstream technology transfer, GMP manufacturing readiness, internal transfer execution, or site implementation activities.

• Proven track record in troubleshooting, deviation support, process robustness assessment, and technical risk mitigation for downstream operations.

• Experience collaborating across regions and functions to align process understanding, transfer strategy, GMP execution, and GMP Facility Management expectations.

• Experience mentoring scientists or engineers and influencing technical decisions without formal line authority.

• バイオ医薬品のdownstream process development、GMP manufacturing、technology tra