Senior Director, Small Molecule CMC Advisor (Analytical Development)
- Compensation
- Not disclosed
- Location
- Fujisawa, Japan
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Full time
- Experience
- 15+ years
- Category
- Not specified
- Posted
Must have
- Education & Experience: Bachelors/ degree 25+ years relevant industry experience. Masters degree 21+ years relevant industry experience. PhD and 15+ years relevant industry experience.
- Leadership & Mentorship: Proven track record of successfully mentoring and elevating junior/mid-level analytical leaders or project managers.
- Business & Operational Acumen: Demonstrated capability to identify and resolve operational bottlenecks and implement successful cost-containment or timeline-acceleration initiatives within CMC models.
- Technical Expertise: Deep knowledge of cGMP regulations, ICH guidelines, and global health authority expectations (FDA, EMA) for small molecule development with technical expertise in synthetic molecu
- Oversight Acumen: 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, d
Full description
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Job DescriptionAbout 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.
Qualifications:
- Education & Experience: Bachelors/ degree 25+ years relevant industry experience. Masters degree 21+ years relevant industry experience. PhD and 15+ years relevant industry experience.