{"id":4317562,"url":"https://alion.io/job/takeda-pharmaceutical-principal-scientist-dissolution-analytical-development-pharmaceutical-sciences","title":"Principal Scientist, Dissolution Analytical Development, Pharmaceutical Sciences","company":{"id":5984,"name":"Takeda Pharmaceutical","domain":"takeda.com","url":"https://alion.io/company/takeda","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":89,"open_postings":79,"ghost_share":0,"stale_share":0.392,"repost_share":0.076,"time_to_fill_p50_days":27,"computed_at":"2026-11-14T05:58:10Z"}},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Fujisawa, Japan"],"countries":["JP"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[],"status":"live","first_seen_at":"2026-11-14T16:50:21Z","employer_posted_date":"2026-11-14","last_verified_at":"2026-11-15T02:20:11Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"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.\nJob Description\nタケダの紹介\n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。\n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）ことを日々の行動指針としています。\n職務について\n本職務では、各プログラムの品質試験・安定性試験、製剤開発、臨床開発、同等性評価を支援する、開発段階に適した溶出試験法の開発、適格性確認、移管および維持を担います。製剤、プロセス開発、品質管理、薬事、外部パートナーなどと連携し、溶出試験および生物薬剤評価の戦略に科学的知見を提供します。分析品質設計、統計的手法、自動化、データ駆動型アプローチを取り入れ、堅牢で識別力が高く、運用上実用的な試験法を確立します。また、技術的に複雑な業務を自律的に主導し、知識の共有や継続的な改善を通じて、グローバルな溶出試験能力の向上に貢献します。\n業務内容\n溶出試験法を開発・維持する 各プログラムの品質試験・安定性試験、製剤開発、臨床開発、同等性評価を支援する、開発段階に適した試験法を開発し、適格性確認、移管および維持を行う\n科学的知見を提供する 製剤、プロセス開発、品質管理、薬事および外部パートナーと連携し、溶出試験および生物薬剤評価の戦略を支援\n堅牢で実用的な試験法を確立する 分析品質設計（AQbD）、統計的手法、溶出試験の自動化およびデータ駆動型のアプローチを活用し、識別力と運用上の実用性を備えた方法を提供\n試験条件を最適化する 装置を選定し、溶出液、撹拌、サンプリング、ろ過などの条件を検討して、試験法の堅牢性を確認\n試験法のライフサイクルを管理する 適格性確認、検証、妥当性確認、移管、トラブル対応を計画・記録し、手順および最新の規制指針に沿って実施\nデータに基づく判断を支援する 溶出プロファイルを適切な統計手法やモデリングで分析し、製剤や同等性に関する意思決定に役立つ知見を提供\n グローバルな技術基盤の向上に貢献する プログラムや拠点間で技術的知見を共有し、調和のとれた溶出試験能力、ベストプラクティスおよび継続的改善を推進\nDevelop, qualify, transfer, and maintain phase-appropriate dissolution methods that support release & stability testing, formulation development, clinical development and comparability assessments across programs.\nProvide scientific input to dissolution and biopharmaceutics strategies, working with formulation, process development, Quality, Regulatory Affairs, and external partners.\nContribute to a globally harmonized dissolution capability and share technical knowledge across programs and sites.\nApply analytical quality by design (AQbD), statistical tools, dissolution automation, and data-driven approaches to deliver robust, discriminating, and operationally practical methods.\n応募資格\n分析化学、製剤、薬科学、化学工学、自動化・ロボティクスなど、関連する科学・工学分野の学士、修士または博士の学位をお持ちの方\n＊職務レベルや業務範囲は、学位と経験に応じて決定\n分析開発または製剤開発において、通常6年以上の関連業界または研究所での実務経験\n溶出試験法の開発経験があり、信頼性の高い試験法の確立または生物薬剤評価の実績をお持ちの方\n製剤開発、生物薬剤評価、分析法の妥当性確認・移管、規格設定または規制対応のいずれかの経験をお持ちの方\n実験を計画し、複雑なデータを解釈し、科学的根拠を文書化したうえで、多分野のチームに提案を伝えられる方\n医薬品分析開発に適用されるデータ完全性および品質要件に関する知識をお持ちの方。GMP試験施設での経験も活かせます。\n優れた文章力・口頭でのコミュニケーション能力を備え、協調性、計画性および問題解決力を発揮できる方\n英語で円滑にコミュニケーションできる能力\n日本語で円滑にコミュニケーションできる能力\nTakeda Compensation and Benefits Summary:\nAllowances: Commutation, Housing, Overtime Work etc.\n\nSalary Increase: Annually, Bonus Payment: Twice a year\n\nWorking 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\n\nHolidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)\n\nPaid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.\n\nFlexible Work Styles: Flextime, Telework\n\nBenefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.\n\nImportant Notice concerning working conditions:\nIt is possible the job scope may change at the company’s discretion.\n\nIt is possible the department and workplace may change at the company’s discretion.\n\nLocations\nFujisawa, JapanWorker Type\nEmployeeWorker Sub-Type\nRegularTime Type\nFull time","description_format":"text","description_chars":3620,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"Japanese","level":"Advanced (C1)","optional":false}]},"benefits":["Flexible schedule"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology 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