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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.
- 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
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MAU.S. Base Salary Range:
$212,000.00 - $333,190.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
For information about our benefits, please click here.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Skills Required
- Bachelor’s degree and 25 or more years of relevant industry experience, or master’s degree and 21 or more years, or PhD and 15 or more years.
- Proven experience mentoring and developing junior- and mid-level analytical leaders or project managers.
- Demonstrated 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 with analytical development, analytical 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.
Takeda Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.
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Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
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Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
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Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.
Takeda Insights
What We Do
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world. We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts. Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives. Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.
Why Work With Us
We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.
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