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神奈川県の求人8,171件応募資格・募集要項・仕事内容を見る
Senior Director, Small Molecule CMC Advisor (Analytical Development)
- 給与
- 記載なし
- 勤務地
- 神奈川県
- 休日
- 年間休日123日
- 雇用形態
- 正社員
- ハイブリッド勤務
- 在宅勤務あり
- 年間休日120日以上
- 賞与あり
- 退職金あり
- 住宅補助
どんな仕事かAIによる生成
The Senior Director, Small Molecule CMC Advisor leads analytical development strategy for the small molecule portfolio and acts as an analytical and CMC subject matter expert across cross-functional development teams. The role guides programs from early-stage candidate selection through late-stage clinical trials and BLA/NDA registration, and advises on initiatives to reduce development costs and accelerate timelines without compromising quality or compliance.
この求人に応募
応募資格
必須
- Bachelors/ degree 25+ years relevant industry experience. Masters degree 21+ years relevant industry experience. PhD and 15+ years relevant industry experience.
- Proven track record of successfully mentoring and elevating junior/mid-level analytical leaders or project managers.
- Demonstrated capability to identify and resolve operational bottlenecks and implement successful cost-containment or timeline-acceleration initiatives within CMC models.
- Deep knowledge of cGMP regulations, ICH guidelines, and global health authority expectations (FDA, EMA) for small molecule development with technical expertise in synthetic molecules and oligosaccharides and/or peptides.
- Proven track record in analytical development/ validation, stability program design and tech transfer as well as a strong knowledge of industry standard practices for nitrosamines, dissolution, solid form characterization, impurity identification and polymorph predication. Extensive experience driving analytical activities within a CMC team as either an Analytical Representative or CMC lead.
募集要項最終確認 10/28
- 職種
- 臨床開発・薬事
- 雇用形態
- EmployeeRegularFull time
- 役職
- Senior Director
- 給与
- 記載なし
- 給与の詳細
- Salary Increase: Annually, Bonus Payment: Twice a year
- 手当
- CommutationHousingOvertime Work
- 勤務地
- Fujisawa, Japan
- 転勤
- It is possible the department and workplace may change at the company’s discretion.
- 働き方
- This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
- 勤務時間
- 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
- 年間休日
- 123日
- 休日・休暇
- Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)Annual Paid LeaveSpecial Paid LeaveSick LeaveFamily Support LeaveMaternity LeaveChildcare LeaveFamily Nursing Leave.
- 福利厚生
- Flexible Work Styles: Flextime, TeleworkRetirement and Corporate PensionEmployee Stock Ownership Program
- 社会保険
- Social Insurance
- 業務の変更の範囲
- It is possible the job scope may change at the company’s discretion.
- 就業場所の変更の範囲
- It is possible the department and workplace may change at the company’s discretion.
- 学歴
- 大学卒業以上
- 掲載日
- 2026/10/28 15:16（1日前）
- 最終確認
- 2026/10/28 21:15（1日前）
仕事内容
About the role:
- We are seeking an experienced and visionary Senior Director, Small Molecule CMC Advisor to lead the analytical development strategy for our small molecule portfolio. In this high-impact leadership role, you will act as the analytical and CMC subject matter expert (SME) across cross-functional development teams, guiding programs from early-stage candidate selection through late-stage clinical trials and BLA/NDA registration. You will mentor and analytical team leaders on our project teams and strategically advise on AD project related initiatives to reduce development costs and accelerate timelines without compromising quality or compliance.
How you will contribute:
- Analytical Strategy & Leadership: Lead and execute comprehensive, phase-appropriate analytical development strategies for drug substances (API) and drug products.
- Talent Mentorship & Growth: Mentor, coach, and guide internal analytical development leaders and scientists, fostering professional growth, technical excellence, and strong project management capabilities.
- Strategic Speed & Cost Optimization: Proactively work with the Analytical Portfolio Leadership and Pharmascience Teams to design and execute strategic initiatives to streamline analytical workflows, reduce costs, and compress timelines to accelerate candidate molecules to clinic and market.
- Specifications & Control Strategies: Establish scientifically justified drug substance and drug product specifications based on batch history, clinical exposure, and stability data. Advise and mentor Analytical Development Team leaders on the development of a holistic control strategy.
- Regulatory Submissions: Author, review, and defend analytical CMC sections for global regulatory filings (IND/CTA, NDA/MAA) and respond directly to health authority inquiries.
- Quality & Investigations: Partner with Quality Assurance (QA) to manage Out-of-Specification (OOS) investigations, deviations, and CAPAs.
- Cross-Functional Collaboration: Act as senior AD advisor assisting the AD team to drive project alignment across project teams alongside Process Chemistry, Formulation, Regulatory Affairs, Quality, and Supply Chain.
この求人は、武田薬品工業株式会社の採用ページの内容をAIが読み取って整理したものです。応募の前に採用ページの原文を確かめてください。データの集め方企業サイト
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