Biologics CMC Director

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Job Description:
About the role:
Join us as our
Biologics CMC Director:
and
lead high-impact, high-visibility CMC projects for innovative biologics in a dynamic global environment.:
You will provide technical and strategic leadership for Chemistry, Manufacturing and Controls (CMC) of one or more late‑stage or commercial biopharmaceuticals with potential upside for the company. You will own the end‑to‑end CMC lifecycle for both Drug Substance and Drug Product, ensuring our manufacturing processes across multiple sites remain at the cutting edge of process technology. In this role, you will lead cross‑functional CMC teams, represent Global Manufacturing Sciences (GMSci) in global product governance forums, and shape the CMC roadmap to support product launches, lifecycle management priorities, submissions, and continuous improvement aligned with Takeda's manufacturing and supply strategy.

How You Will Contribute:
As the principal product technical leader, you drive innovation and transformation with direct influence on the company's success and future growth. Reporting to the Head of GMSci CMC, you will

• Set and own the CMC lifecycle management strategy and roadmap for assigned biologic products.
• Ensure manufacturing processes remain robust, performant, aligned with QbD principles, and comparable across multiple internal and external manufacturing sites.
• Lead cross‑functional CMC teams to plan and execute short- and long-term CMC activities for product pre and post launch including, but not limited to, technology transfers, second generation processes, process improvements, post marketing commitments.
• Provide expert guidance and technical oversight for investigations, troubleshooting, process optimization, and major process or method changes.
• Be part of global product and governance teams, driving clear decisions on CMC strategy, lifecycle management and technology excellence.
• Drive preparation and support of CMC content for regulatory submissions (initial filings, market expansions, post‑marketing changes, and regulatory commitments).
• Act as a subject matter expert in regulatory inspections and audits, ensuring consistent, science‑based communication of product and process knowledge.
• Identify and lead implementation of innovation and continuous improvement initiatives – process improvements, new technologies, and data‑driven approaches to reduce COGs and strengthen supply reliability.
• Collaborate closely with an assigned CMC Project Manager (who will provide you PM support).
• Continuous interaction with Process & Product Sciences, Analytical Development, Site Manufacturing Sciences, QA, QC, Engineering, Supply Chain, Validation and Regulatory CMC to ensure aligned, efficient CMC execution across functions and sites.
• Mentor colleagues and contribute to building CMC expertise and best practices across the GMSci Biologics organization.

What You Bring to Takeda:

• Advanced degree (Master's or higher preferred) in engineering or life sciences.
• At least 10 years of experience in pharmaceutical or biopharmaceutical development/manufacturing, with substantial exposure to biologics Drug Substance and Drug Product.
• Proven experience in product and process lifecycle management, including post‑approval changes, technology transfers, and continuous improvement.
• Deep technical understanding of biologics manufacturing, quality, and regulatory frameworks, and how to apply these in CMC strategy and execution.
• Demonstrated ability to lead complex, cross‑functional initiatives in a global, matrixed environment.
• Strong analytical and problem‑solving skills, with a track record of making sound, data‑based decisions on complex technical topics.
• Effective stakeholder management and communication skills, including experience interacting with senior leaders and health authorities.
• Fluency in English (spoken and written); Mandarin is an advantage but not required.
• Behaviours aligned with Takeda's values enterprise and strategic thinking, focus on delivering results that matter for patients, ability to create an inclusive and empowering environment, and commitment to developing capabilities for the future.

More About Us:
At Takeda, we are committed to delivering high-quality products to patients worldwide. We strive for excellence in everything we do, fostering a culture of innovation and continuous improvement. Join us and contribute to our mission of improving health and well-being through leading-edge science and technology.

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:
USA - MA - Hayden

U.S. Base Salary Range :
$174, $274,230.00

The 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.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.
Locations:
USA - MA - Hayden CHE - Glattpark (Opfikon) - Zurich HQ

Worker Type:
Employee

Worker Sub-Type:
Regular

Time Type:
Full time

Job Exempt:
Yes

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