Senior Director, Small Molecule CMC Advisor (Analytical Development)

Takeda • Boston, MA

2d • $212,000 - $333,190 • Hybrid

About The Position

Takeda is seeking a 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 advisor mentors analytical team leaders and provides strategic guidance on analytical development initiatives intended to reduce development costs and accelerate timelines without compromising quality or compliance.

The position is classified as hybrid under Takeda’s Hybrid and Remote Work policy and is based in Boston, Massachusetts. It is a regular, full-time employee position. The stated U.S. base salary range for Boston is $212,000 to $333,190; the actual offer may vary based on qualifications, experience, skills, education, certifications or licenses, and location.

Requirements

• Bachelor’s degree and 25+ years of relevant industry experience, or a master’s degree and 21+ years of relevant industry experience, or a PhD and 15+ years of relevant industry experience.
• Proven track record of mentoring and developing junior- or mid-level analytical leaders or project managers.
• Demonstrated ability 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, including FDA and EMA requirements for small molecule development.
• Technical expertise in synthetic molecules and oligosaccharides and/or peptides.
• Proven experience in analytical development and validation, stability program design, and technology transfer.
• Strong 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 internal analytical development leaders and scientists, supporting professional growth, technical excellence, and project management capabilities.
• Work with Analytical Portfolio Leadership and Pharmascience Teams to develop and execute initiatives that streamline analytical workflows, reduce costs, and accelerate 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, and respond directly to health authority inquiries.
• Partner with Quality Assurance to manage Out-of-Specification investigations, deviations, and CAPAs.
• Serve as a senior analytical development advisor, helping drive project alignment across teams in collaboration with Process Chemistry, Formulation, Regulatory Affairs, Quality, and Supply Chain.
• Provide analytical development leadership across programs from early candidate selection through late-stage clinical trials and BLA/NDA registration.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree