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Takeda Pharmaceutical Company Limited
The Pharmaceutical Sciences (Pharm Sci) organization is an integral part of global R&D at Takeda, translating science into therapeutic products for patients. When you join Pharm Sci, you become part of a team dedicated to bringing our products to life for our patients through innovation, dedication and talent while minimizing environmental impact.
We work as a member of Takeda’s Global Program Team (GPT) and take full ownership of Chemistry, Manufacturing & Control (CMC) activities — driving product development from bench to bedside.
The Pharm Sci team focuses on executing and enhancing business processes and partnering with key stakeholders and industry leaders to boldly deliver an increasingly complex portfolio. Always looking through a sustainability lens to protect our planet, we are embracing new ways of working, excelling in our data and digital transformation, building differentiated capabilities (CMC Acceleration), delivering innovative medical devices, and advancing an inclusive, innovative culture.
It is an exciting time to be in Pharm Sci. Join our journey and change the lives of patients!
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’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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。
タケダは国内第一の製薬企業、そして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。
募集部門の紹介
アナリティカル・デベロップメントは、グローバル体制で物性から医薬品候補を導き、革新的な分析技術を活用して品質設計戦略を構築、品質の「ものさし」を創り、品質を保証することで、世界中の病に苦しんでいる患者さんに新薬を研究・開発しています。
物性評価、試験法開発、治験薬の品質評価/安定性評価、製造販売承認申請業務などを通じて、グローバルに跨るファーマシューティカルサイエンスチームの一員として、画期的な新薬創出に貢献しています。
低分子のみならず多様なモダリティを扱っており、特に核酸・ペプチドなどの中分子、タンパクやナノ粒子などの新規モダリティの医薬品は、物性評価や品質試験法が未確立である場合が多いため、新技術の導入や応用を行い、これらの確立を通じて新薬の研究開発、製品化に寄与しています。
職務内容
治験薬製造施設の環境モニタリング(Environmental Monitoring, EM)業務の管理・実行
治験薬製造施設の環境・用役管理に関わるGMP書類の作成/確認
分析法に関連するGMP文書、適格性評価/バリデーション文書、その他のGMP文書の作成/承認
査察/監査/問い合わせへの対応 査察/監査/書面調査の対応/協力
CRO/CTO/CMO/CDMO 等の外部試験機関の管理、業務の管理
新規分析法の開発、その他の試験法開発に関わる業務
EM電子システム構築への参画、評価、実装
応募要件
大卒・高専卒 以上で、バイオテクノロジー、微生物学等の分野を選考された方、もしくは同等の知識・経験・スキルを有する方
微生物関連分析を中心に、医薬品および医薬品候補品の分析・品質管理にかかわる3年程度以上の業務経験を有することが望ましい
EM業務の経験(EMサンプルの収集、傾向分析、製薬用水の微生物学的検査など)
医薬品および医薬品候補品の品質試験・微生物試験に関する一般的知識・基礎研究ならびに開発分析業務の実務経験
医薬品試験施設・製造施設での品質試験・微生物試験・環境モニタリングに関する知識
cGMPやICHガイドラインなど医薬品に関する規制(レギュレーション)に関する知識および経験
無菌性保証に関連する規制要件/ガイダンスの理解
科学的知識と客観分析力に基づく問題解決能力
英語力：ビジネスレベル（論文執筆・口頭プレゼンテーションおよび質疑応答が可能、TOEIC700程度以上が望ましい）
日本語：国内メンバーとのビジネスディスカッション、当局への申請書類作成・照会事項対応が可能なレベル
デジタル化・デジタル化推進経験
CMCでの解析開発アクティビティの理解
求める人物像
プロジェクトにて、様々な部署の関係者を適切に巻き込み、ゼロベースで考える・従来の枠を越えたオプションを検討するなど、医薬品の開発推進に説明責任と熱意をもって取り組める方
社内外・国内外のステークホルダーと信頼を育み、協働できる方
実務経験に裏打ちされた専門性(分析技術・信頼性保証・GMPなど)を有する方
グローバル組織の一員として活躍・協働できる能力・マインドセットを有する方
仕事のやりがい
非臨床段階から製造承認取得の幅広い開発段階に渡って、グローバル開発品目はじめ様々な医薬品候補品の分析試験法開発業務、分析による治験薬製造のサポートにより、画期的医薬品の創製に貢献することができます。
近年の研究開発加速化に伴い、各人が担当する開発品目への責任を持って、新たなプロセスを切り拓くことも増えています。多様なモダリティの研究開発に伴って新規技術やコンセプトの導入、デジタル技術の活用なども予定しており、やりがいのある職種です。
本職務で身につくスキル・経験
低分子医薬品のみならず種々のモダリティの品質管理戦略設計、微生物関連試験、海外も含めたレギュレーションに関する知識ならびに実務経験
グローバルプロジェクトへの参画・開発経験
タケダのダイバーシティ＆インクルージョン
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.
Our teams are experienced in medicinal chemistry, multi-step synthesis, multimodal genetics, genomics datasets, pharmacokinetics and more. So wherever your expertise and passion lie, your work will have tangible outcomes, advancing an innovative pipeline that serves unmet needs.
We're delving deeper than ever inside the human body and its microbiome, implementing innovative approaches to deliver high-quality products that treat a range of illnesses, including IBD and cancer.
In our diverse, forward-thinking culture, we're constantly embracing new ways of working:
On our team in Pharmaceutical Sciences, you’ll notice a big difference in your own life, too. You’ll be supported to develop your career. You'll connect with brilliant minds and be recognized for your accomplishments. Your curiosity, skills and dedication will have a place and a purpose. So even when you’re exploring the smallest of details, your world will be bigger than ever.
Perform cell processing operations
Support clean room activities
Ensure equipment maintenance
Support investigations in deviations
Along with incredibly passionate colleagues, there’s a clear commitment to invest in the best facilities and the right equipment needed to successfully perform world-class science.
Christina Alves - Head of Biotherapeutics Process Development
Within Takeda, there’s a lot of room for disruption and challenging how things have been done before.
Briana Rawson - Lead, Human Factors Engineer
I love that I get to connect smaller, newer ventures with Takeda’s reputation and resources so that we can develop innovative ways of diagnosing and managing the conditions of patients with unmet needs.
Rachel Whitaker - Principal Engineer, Diagnostic Devices
The heart of our work
Leading with innovation
Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.
Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.
Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.
We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.
Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.
Integrity
Fairness
Honesty
Perseverance
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission.Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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