武田薬品工業株式会社のAssociate Scientific Fellow, Downstream Technology Transfer Lead, Drug Substance Operations, Biotherapeutics Process Development, Pharmaceutical Sciences求人

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

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.

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。

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.

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.

＜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.

＜スキル・資格＞
· Strong expertise in downstream unit operations, including chromatography, filtration, viral clearance, UF/DF, impurity clearance, and process robustness.
· Solid knowledge of cGMP, quality systems, deviation management, process validation concepts, and technology transfer expectations for biologics manufacturing.
· Ability to translate downstream process knowledge into executable GMP manufacturing plans, transfer documentation, and risk mitigation strategies.
· Strong analytical thinking and problem-solving skills with the ability to lead technical discussions across global and cross-functional stakeholders.

＜語学＞
· Native-level Japanese proficiency in speaking, business writing, and reading.
· Strong verbal and written communication skills in English.
· Ability to lead technical discussions, presentations, meetings, and scientific/business documentation in English within a global environment.

＜その他＞
求める人物像
· A patient-focused scientific leader who demonstrates Takeda-ism through daily behaviors.
· A collaborative professional who can work effectively in a global and cross-functional environment.
· A proactive technical expert who can translate scientific knowledge into practical GMP manufacturing execution.
· A leader who values scientific rigor, operational feasibility, quality, compliance, and timely delivery.