Principal Scientist or Associate Scientist, Analytical Controls Japan, Analytical Controls

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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

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 - were looking for like-minded professionals to join us.

Takeda is the number one pharmaceutical company in Japan and a global industry leader we are united by our four priorities (Patients Trust Reputation and Business) and our shared values ofTakeda-ism: Integrity Fairness Honesty and Perseverance. Takeda-ism is more than just a word. Its a belief and a mindset which guides our decisions behaviors and interactions. Its how we strive to work and live every day.

OBJECTIVES/PURPOSE

Contribute proactively to pipeline development and strategic discussion as a cross functional team member to plan/coordinate and evaluate impact of decisions across Pharm Sci functions and other development functions.
Iindependently lead and manage the external GMP testing activities and shelf-life setting strate-gies for drug substance and drug product to deliver the high quality and innovative medicines to patients through the strategic planning and execution including complex problem solving like la-boratory investigations and technical management of external vendors for pharmaceutical devel-opment until the commercial launch.
Oversight and approval of analytical method validation verification and transfer documents for testing readiness at the GMP testing site.
Prepare and coordinate completion of relevant CMC sections of regulatory documents and re-ports within expertise for regulatory submission.
Required to be recognized as an expert of analytical GMP compliance such as data integrity GMP documentation and management statistics for stability and shelf-life predictions GMP reg-ulated information management systems (LIMS DMS) based on solid understanding of industry standards on analytical methods for synthetic molecules (i.e. small molecules Oligo nucleotides and Peptides) and biologics.

パイプライン開発および戦略的議論に部門横断チームの一員として参画し各種計画/調整ならびにその影響評価を進めながら自部門および他部門における意思決定に積極的に貢献する
商用前までの開発段階における治験薬(原薬および製剤)GMP試験ならびに有効期間設定戦略を自律的に牽引し品質イベント時の試験室調査や社外委託先のマネジメント等の複雑な問題解決等を含む戦略的な開発計画と実行を通じて高品質で革新的な医薬品を患者様に届ける
原薬および製剤試験法の適格性確認やバリデーション移管を包括的に監督並びに関連文書を承認しGMP試験サイトを立ち上げる
薬事関連文書の該当するCMCセクション医薬品申請用資料の作成と調整を行う
合成医薬品低分子オリゴヌクレオチドペプチドならびに生物製剤候補品につき業界標準の分析試験法への確かな理解に基づいてデータインテグリティGMP文書化及び管理SOPの作成といった試験関連のGMPコンプライアンス安定性ならびに有効期間予測などの統計学GMP情報管理システム(LIMS 文書管理システム)などの能力を有する専門家として広く認められる

ACCOUNTABILITIES

Manage GMP testing and relevant activities for investigational products (i.e. drug substance and drug product) to generate Takeda official CoA and stability outcomes including leading laboratory investigations
Strategy and oversight of review/approval of method validation and transfer documents
Manage external testing partners such as CTOs CDMOs and CROs to be compliant under GMP and meet the development timelines.
In collaboration with commercial functions handover of the product knowledge obtained in GMP testing throughout development stage and align with PPQ/post-approval stability study designs.
Build and maintain good partnership with internal / external partners and stakeholders such as CTOs CDMOs and Takedas R&D and commercial organizations.
Understand and implement regulatory knowledge such as FDA EMA PMDA and ICH guidelines for analytical validation stability studies and analytical Quality by Design (QbD).
Deliver high quality and reliable data for patient safety during clinical trials to make critical project decisions related to and in collaboration with Pharmaceutical Sciences Team.
Prepare and present comprehensive technical and/or project reports and formal presentations to a full range of internal / external audiences.
Contribute to establishing and managing operational processes with the department/function including harmonization and standardization Analytical Controls and Analytical Development (but also PharmSci) processes in collaboration with Quality partners.
Lead and contribute to strategic initiatives and activities within the organization to increase productivity of pipeline development and technical capabilities
Participate in defining and coordinating department priorities and strategies
Recognized as a technical expert across Pharm Sci functions
Serve as a technical resource or mentor for junior staff and leverage expertise in GMP compli-ance driving pipelines and relevant regulatory knowledge as a functional resource/trainer

治験薬(原薬および製剤)につきGMP試験ならびに関連案件を品質イベント時の試験室調査のリードを含めてマネージし武田試験成績書(CoA)ならびに安定性成績書を作成する

試験法バリデーションならびに移管文書につき戦略を理解しレビューならびに承認を行う
社外委託先(CTO CDMOならびにCRO) をTakeda GMP基準に準拠するよう管理し開発スケジュールを遵守する
商用生産分析部門と協力し開発段階で蓄積されたGMP試験に関する製品知識を引継ぎPPQならびに承認後安定性のデザインについて合意を得る
CTOCDMOタケダR&D商用生産分析部門などの社内外のパートナーとの良好な関係を構築し維持する
FDAEMAPMDAICHガイドラインなどの規制に関する知識を理解し分析法バリデーション安定性試験Analytical Quality by DesignQbDなどに実装する
臨床試験における患者様の安全性のために高品質で信頼性の高いデータを提供するひいてはそれらを基にプログラム開発チームに関連する重要な意思決定を共に行う
包括的な技術報告書やプロジェクト報告書を作成し社内外のあらゆる聴衆に対して適切なプレゼンテーションを行う
Analytical Controls及びAnalytical Development (Pharmaceutical Scienceの場合も含む)での三極調和や標準化など所属グループ/研究所の業務の進め方を確立牽引する活動に貢献する
パイプライン開発の生産性および技術能力を向上させるための組織内の戦略的イニシアティブおよび活動を主導し貢献する
部門の優先順位と戦略の定義と策定に参加する
部門全体から技術専門家として認められる
若手スタッフのメンターとして自らのGMPコンプライアンスパイプライン開発ならびに関連する規制に関する知見などの専門知識を活用し教育に役立てる

EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS

Bachelors degree in chemistry Engineering Biology Analytical Chemistry or related Pharma-ceutical Science and 7 years relevant industry experience
Masters degree in chemistry Engineering Biology Analytical Chemistry or related Pharmaceuti-cal Science and 5 years relevant industry experience
PhD in Chemistry Engineering Biology Analytical Chemistry or related Pharmaceutical Science and 3 years relevant industry experience
Extensive experience in CMC pharmaceutical development for drug substances and drug prod-ucts of synthetic molecules (small molecules and/or oligonucleotides) under cGMP
Has developed expertise in multiple areas of analytical technology and demonstrate an in-depth working knowledge of program strategy. Experienced with working on late-stage assets with var-ious regulatory agencies and GMP Audit (Experience in Health Authority Inspections preferred.)
Knowledge and experiences on each of industry standard analytical techniques to consolidate those outcomes and interpret them to product quality as well as working in a lab setting. (LC dissolution KF particle size analysis XRPD etc.)
Experiences with method development (nice to have) validation (phase appropriate and/or ICH) and transfer; Ability to review a design and analytical strategy to meet CMC project objectives.
Ability to analyze a wide variety of information and data with capabilities of statistics and in silico modelling to make management decisions regarding potential risks associated with product quali-ty and regulatory compliance.
Excellent organizational and communication skills. Has the ability to influence at all levels of the organization and manage projects across businesses and the globe.
Experience in writing regulatory documents with sound knowledge of current cGMP
Excellent command of English (oral and written) and Japanese

化学工学生物学分析化学またはCMC研究に関連する分野において学士を取得し7年以上の関連業界経験を有すること
化学工学生物学分析化学またはCMC研究に関連する分野において修士を取得し5年以上の関連業界経験を有する
化学工学生物学分析化学またはCMC研究に関連する分野において博士を取得し3年以上の関連業界経験を有する
cGMP下での合成分子低分子およびオリゴヌクレチドの原薬および製剤のCMC医薬品開発における豊富な経験を有する
複数の分析技術における専門知識を有しプログラム戦略に関する深い実務知識を有すること後期段階のパイプラインや様々な規制当局との折衝の経験やGMP監査(当局査察経験があればなお可)があること
業界標準の各分析技術に関する知識と経験を持ちそれらの結果を統合して製品品質に解釈する能力およびラボでの試験実施経験LC溶出性KF粒度分布XRPDなど
分析法開発経験があればなお可開発段階またはICHバリデーションおよび移管に関する経験CMCプロジェクトの目標達成のための分析戦略を理解ならびにレビューする能力を有する
統計学in silicoモデリングを駆使して様々な情報やデータを分析し製品の品質や規制に関連する潜在的リスクに対して評価判断する能力を有する
優れた組織形成とコミュニケーション能力を有する組織のあらゆるレベルに影響力を持ち事業や世界をまたがるプロジェクトを管理する能力を有する
現行のcGMPに関する確かな知識と規制関連文書の作成経験を有する
ビジネスレベルの英語能力(スピーキングライティング含む)と日本語能力

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 companys discretion.

• It is possible the department and workplace may change at the companys discretion.

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