Principal or Associate Scientist, Process Testing & Management Analytical Development Japan
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Job Summary
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Job Description
Please note this job requires business level Japanese in speaking writing and reading.
タケダの紹介
タケダは世界中の人々の健康と輝かしい未来に貢献することを企業の存在意義パーパスとしていますそして目指す未来を共有しながら一人ひとりが自分の可能性を引き出しお互いの個性を認め合う多様性にあふれた先進的な組織作りに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
タケダはグローバルな研究開発型のバイオ医薬品のリーディングカンパニーです従業員は創業時から受け継いできたタケダの価値観であるタケダイズム誠実公正正直不屈を道しるべとしながら患者さんに寄り添いPatient人々と信頼関係を築きTrust社会的評価を向上させReputation持続可能な事業を発展させるBusinessを日々の行動指針としています
- バイオ医薬品原薬および無菌製剤のGMP製造分析についてプロセス管理とリリース試験を実行主導しcGMP基準品質規制要件への厳格な遵守を確保する
- 部門横断的なGMP製造運営チームと連携し戦略的計画策定と業務効率化を推進プロセス分析開発技術移転適応型製造に積極的に貢献し組織の成功を促進するとともに社内分析能力の向上を図る
- 原薬および製剤の分析法開発適格性確認バリデーションをリードし品質規格設定や複雑な問題解決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
- パイプラインの開発および戦略的議論に参画し部門横断的なメンバーとの計画/調整を行い自部門および他部門における迅速な意思決定に貢献する
ACCOUNTABILITIES :
- J-GMPUS-cGMPEU-GMP基準を厳格に遵守し高品質なバイオ医薬品原薬および無菌製剤治験薬CTMの適時提供を担当する
- 社内の品質要求事項に沿いコンプライアンスリスクを最小化しcGMP準拠を確保する包括的なプロセス及び品質管理戦略を構築する
- 分析管理戦略の効果的な実行に向け社内スタッフの統率および外部委託先ベンダーとの調整を主導する
- 社内外のGMP規制検査への対応態勢を確保するための戦略を主導し実施する
- グローバル品質部門の同僚と連携しグローバル業務を強化する改善策を特定実施する
- 合成医薬品候補品の原薬および製剤についてICHガイドラインに準拠した信頼性の高い分析法を開発し適切な方法でバリデートする
- 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開発安定性試験Analytical Quality by DesignAQbDを実施する
- プログラム開発チームと連携し重要な意思決定を行うために高品質で信頼性の高いデータにつながる確実な科学的実験を実施する
EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS:
- 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5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3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
- バイオ医薬品もしくは合成分子低分子およびオリゴヌクレチドにおける試験方法開発工程内試験GMPリリース試験に関する深い知識と技術
- 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開発パイプラインの担当や様々な規制当局との折衝の経験があること
- 分析法開発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を達成するための分析戦略を立案し指示する能力
- 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
タケダのDEI
Better Health Brighter Future
OBJECTIVES/PURPOSE
- Execute and lead process control and release testing for biologics GMP manufacturing and sterile drug products for clinical trial materials ensuring rigorous compliance with cGMP standards quality and regulatory requirements.
- Execute strategic planning and operational excellence with cross-functional GMP manufacturing and operating team actively contributing to process & analytical development technology transfer and adaptable manufacturing to drive organizational success and elevate in-house analytical capability
- Lead the development of analytical methods qualification and validation for drug substance and drug product to deliver the high quality and innovative medicines to patients through the strategic planning and execution including specification setting and complex problem solving for pharmaceutical development.
- Contribute to pipeline development and strategic discussion to plan/coordinate with cross-functional members and evaluate impact of decisions across Pharm Sci functions and other development functions.
ACCOUNTABILITIES
- Responsible for timely and quality delivery of Biologics clinical trial materials (CTMs) in strict compliance with J-GMP US-cGMP and EU-GMP standards.
- Create the holistic process and quality control strategy that aligns with Takedas quality expectations minimizes compliance risks and ensures cGMP compliance
- Lead internal staff and coordinate with outsourced personnel/vendors to execute the analytical control strategy effectively.
- Lead and implement strategies to ensure readiness for internal and external GMP regulatory inspections.
- Collaborate with Global Quality colleagues to identify and implement improvements that enhance global operations.
- Develop and validate ICH compliant and reliable analytical methods for drug substnace and drug products of synthetic molecules in phase appropriate manner.
- Build and maintain good partnership with internal / external partners 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 development stability studies and analytical Quality by Design (QbD).
- Deliver sound scientific experiments that lead to high quality and reliable data to make critical project decisions related to and in collaboration with Pharmaceutical Sciences Team.
EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelors degree in Chemistry Engineering Biology Analytical Chemistry or related Pharmaceutical Science and 5 years relevant industry experience
- Masters degree in Chemistry Engineering Biology Analytical Chemistry or related Pharmaceutical Science and 3 years relevant industry experience
- PhD in Chemistry Engineering Biology Analytical Chemistry or related Pharmaceutical Science and 3 years relevant industry experience
- In depth knowledge and skills of testing method development in-process testing and GMP release testing for biologics or synthetic molecules (small molecules and/or oligonucleotides) under cGMP.
- Have developed expertise in multiple areas of analytical technology and demonstrate an in-depth working knowledge of program strategy. Experienced with working on development assets and with various regulatory agencies
- Experience with method development validation (phase appropriate and ICH) and transfer; Ability to design and direct analytical strategy to meet CMC project objectives
- 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
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.
Locations
Fujisawa JapanWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeRequired Experience:
Staff IC
Key Skills
- Machine Learning
- Python
- Data Science
- AI
- R
- Research Experience
- Sensors
- Drug Discovery
- Research & Development
- Natural Language Processing
- Data Analysis Skills
- Toxicology Experience
About Company
Takeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.
