Senior Director, Small Molecule CMC Advisor (Analytical Development) Fujisawa, Fujisawa, Kanagawa Category: Pharmaceutical Sciences

Job description

Please be aware of identity thieves actively posing as Takeda employees or recruiters posting Takeda-branded jobs online to steal personal information from job seekers. We care about your privacy and candidate experience. Learn more about how to spot fraudulent messages here. Our application process will be unavailable for scheduled maintenance from Saturday , August 1 at 5:00 AM ET through Sunday, August 2 at 4:00 AM ET . To be notified when applications are available again, please share your contact information here. --> Skip to main content Job Posting Find jobs for Location Radius Senior Director, Small Molecule CMC Advisor (Analytical Development) Fujisawa, Kanagawa Apply Now Job ID R0193367 Category Pharmaceutical Sciences Subcategory Research & Development Business Unit Research & Development Job Type Full time 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 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. Qualifications: 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 molecules and oligosaccharides and/or peptides. 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, 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. This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. 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 Apply Now Share this job Facebook Xing LinkedIn Email Related content Learn more Frequently Asked Questions Learn more Healthcare for all Learn more How We Partner Learn more Innovators in Science Award Winners Learn more Luck is not a strategy Learn more Takeda Unveils Newly Renovated Cambridge Building Learn more Our Commitment to the Planet Learn more Our Products Learn more Our R&D Pipeline Learn more Patient Story: Rosie Learn more Putting Patients First Learn more Sustainable Value Report 2023 Learn more Takeda Global Headquarters Learn more Informiere dich über Stellenangebote Takedas Produktionsstandort Learn more Takeda in the US Learn more Takeda’s Global CSR Program Learn more The History of Takeda Learn more Values and Corporate Governance Learn more Takeda Manufacturing - 2021 Facilities of the Year Learn more Takeda Acquires Adaptate Therapeutics Learn more BioLife Plasma Services Learn more <li class="js-hub-item hub-content__item showing-by-filter showing-by-load" data-hub-read-time="" data-hub-origin="False" data-hub-title="Biotech Site in Covington, GA" data-hub-meta-title="" data-hub-meta="" data-hub-url="jobs.takeda.com/" data-hub-isfallbackpage="False" data-hub-order="0" data-hub-link="https://www.youtube.com/watch?v=t1HfwPrnkMA" data-hub-image="https://tbcdn.talentbrew.com/company/1113/v3_0/img/content/rc_biotech_site_covington_ga.jpg" data-hub-created-by="TMP created" data-hub-date-updated="02/26/2025 19:36:53" data-hub-date-created="02/26/2025 19:36:53" data-hub-date-override="07/06/20