Senior Director, Small Molecule CMC Advisor (Analytical Development)
About The Position
Takeda is seeking an experienced Senior Director, Small Molecule CMC Advisor to lead analytical development strategy for its small molecule portfolio. The role serves as an analytical and CMC subject matter expert across cross-functional development teams, guiding programs from early-stage candidate selection through late-stage clinical trials and BLA/NDA registration. The position mentors analytical team leaders and advises on analytical development initiatives intended to reduce development costs and accelerate timelines while maintaining quality and compliance. The role leads phase-appropriate analytical development strategies for drug substances and drug products; establishes scientifically justified specifications and advises on holistic control strategies; and authors, reviews, and defends analytical CMC content for global regulatory filings. It partners with Quality Assurance on investigations and collaborates with Process Chemistry, Formulation, Regulatory Affairs, Quality, and Supply Chain to align projects. The position is classified as hybrid and is located in Boston, Massachusetts.
Requirements
- Bachelor’s degree and 25 or more years of relevant industry experience, or a master’s degree and 21 or more years, or a PhD and 15 or more years.
- Proven success mentoring and developing junior- or mid-level analytical leaders or project managers.
- Ability to identify and resolve operational bottlenecks and implement cost-containment or timeline-acceleration initiatives within CMC models.
- Deep knowledge of cGMP regulations, ICH guidelines, and global health authority expectations, including FDA and EMA requirements, for small molecule development.
- Technical expertise in synthetic molecules and oligosaccharides and/or peptides.
- Experience in analytical development and validation, stability program design, and technology transfer.
- Knowledge of industry practices for nitrosamines, dissolution, solid-form characterization, impurity identification, and polymorph prediction.
- Extensive experience driving analytical activities within a CMC team as an Analytical Representative or CMC lead.
Responsibilities
- Lead and execute phase-appropriate analytical development strategies for drug substances (API) and drug products.
- Mentor, coach, and guide analytical development leaders and scientists, supporting professional growth, technical excellence, and project management capabilities.
- Work with Analytical Portfolio Leadership and Pharmascience Teams to streamline analytical workflows, reduce costs, and accelerate development timelines.
- 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 development of holistic control strategies.
- Author, review, and defend analytical CMC sections for global regulatory filings, including IND/CTA and NDA/MAA submissions.
- Respond directly to health authority inquiries.
- Partner with Quality Assurance to manage Out-of-Specification investigations, deviations, and CAPAs.
- Advise analytical development teams and promote project alignment with Process Chemistry, Formulation, Regulatory Affairs, Quality, and Supply Chain.
- Drive analytical activities within a CMC team as an Analytical Representative or CMC lead.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
