Principal or Associate Scientist, Process Testing & Management Analytical D at Takeda Pharmaceutical Company Limited USA

Fujisawa, , Japan -

Full Time

Start Date

Immediate

Expiry Date

16 May, 26

Salary

0.0

Posted On

15 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Control, Release Testing, cGMP Compliance, Analytical Method Development, Validation, Technology Transfer, Quality Control Strategy, Regulatory Inspection Readiness, ICH Guidelines, Analytical Quality by Design (AQbD), Problem Solving, Stakeholder Management, Organizational Skills, Communication Skills, Biologics Manufacturing, Sterile Drug Products

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 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-GMP、US-cGMP、EU-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。 CTO、CDMO、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。 FDA、EMA、PMDA、ICH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 Design（AQbD）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DE＆I 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 Takeda's 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 Takeda’s 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: Bachelor’s degree in Chemistry, Engineering, Biology, Analytical Chemistry or related Pharmaceutical Science and 5+ years relevant industry experience Master’s 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 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 executing and leading process control and release testing for biologics GMP manufacturing and sterile drug products, ensuring strict adherence to cGMP, quality, and regulatory standards. This includes leading analytical method development, validation, and strategic planning for pipeline development in collaboration with cross-functional teams.