Principal Scientist/ Associate Scientist, Drug Product & Device Development at Takeda Pharmaceutical Company Limited USA

Fujisawa, , Japan -

Full Time

Start Date

Immediate

Expiry Date

22 Dec, 25

Salary

0.0

Posted On

24 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Oral Dosage Formulation, Process Development, Project Management, Regulatory Documentation, Communication Skills, Collaboration, Pre-formulation Research, Process Analytical Technology, In Silico Modeling, Clinical Trial Applications, CMC Documentation, Regulatory Knowledge, Technical Transfer, Scale-Up, Drug Delivery Systems, Pediatric Formulations

Industry

Pharmaceutical Manufacturing

Description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please note this job requires native level Japanese language command not only in speaking, business writing and reading. 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組んで取り組んでいます。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’re 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’s a belief and a mindset which guides our decisions, behaviors, and interactions. It’s how we strive to work and live, every day. 募集部門の紹介創薬研究より見出される新薬候補化合物の有効性・安全性を最大限に高め、かつ、患者さんにとって服用しやすい”カタチ”へ仕上げていくためには、製剤化する技術が不可欠です。治療モダリティの多様化に伴い、必要とされる製剤技術や投与ルートも多様化する中で、我々は、最適な技術と剤形の選択により候補化合物の課題を解決し、患者さんのQOL・利便性向上を目指して研究・開発を行っています。前臨床段階から、臨床試験、薬事申請、製品上市まで開発プログラムに参画し、グローバルおよびローカルの関係部門と連携しながら、製品設計、プロセス開発、治験薬製造、スケールアップ・技術移管、薬事申請などを行います。職務内容経口製剤に関する処方設計及び製造プロセスの開発製造・開発委託先のマネジメントや治験薬供給業務後期開発品のスケールアップ検討および国内・海外製造サイトへの技術移管治験及び申請ドキュメントの作成製剤担当者として製剤開発の方針、予算・タイムライン調整などをグローバルの開発部門と連携して行う応募要件理系大学卒以上、理系大学院（修士）卒以上が望ましい 5年以上の経口製剤の製剤設計もしくは工業化業務経験同僚や海外委託先とコミュニケーションを取って業務を行える英語力望ましい要件（以下全てを満たす必要なし）プレフォーミュレーション研究経験 DDS製剤、小児製剤、難溶性化合物用製剤などの開発経験プロセス分析技術（PAT）の開発経験 In silicoモデリングやプロセスシミュレーションの活用経験治験申請(IND/IMPD)や承認申請（NDA/MAA）におけるCMCドキュメント作成及び照会事項対応経験国内・海外のレギュレーション、ガイドラインに関する知識＜その他＞海外出張に対応できる方が望ましい求める人物像国内外の関係部門と協調・連携が重要な業務であり、コミュニケーション能力に自信がある方、またグローバル環境に挑戦されたい方は是非応募ください。タケダのDE＆I Empowering Our People to Shine Takeda Compensation and Benefits Summary: Allowances: Commutation, Housing, Overtime Work etc. Salary Increase: Annually, Bonus Payment: Twice a year Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45 Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year) Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave. Flexible Work Styles: Flextime, Telework Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc. Important Notice concerning working conditions: It is possible the job scope may change at the company’s discretion. It is possible the department and workplace may change at the company’s discretion. Locations Fujisawa, Japan Worker Type Employee Worker Sub-Type Regular Time Type Full time Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer. For applicants of U.S and Puerto Rico positions: Click here to learn about our commitment to Equal Employment Opportunity (EEO). If you are limited in the ability to use our job application tool, or otherwise require a reasonable accommodation for a disability please click here.

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Responsibilities

The role involves the design and development of oral dosage formulations and manufacturing processes. It also includes managing contract manufacturers and preparing documentation for clinical trials and regulatory submissions.