CMC Lead, Launch Product, Biologics (Director)
Lexington, KY - USA
Job Summary
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Job Description
About the role
As CMC Lead for a key biologics launch product you will serve as the central scientific and strategic leader for Chemistry Manufacturing and Controls (CMC) activities across the product lifecycle. You will partner closely with Global Product Teams and Pharmaceutical Sciences to drive development commercialization and ongoing innovation.
This role offers the opportunity to influence high-impact decisions shape life cycle management strategies and advance technology excellence across Takedas biologics portfolio on a global scale. You will report into the Head of MSAT Biologics.
How you will contribute
- Lead cross-functional CMC teams to advance development and lifecycle management for a key biologics asset ensuring alignment across Pharmaceutical Sciences and GSQ
- Represent CMC in Global Product Teams providing strategic input that directly impacts program outcomes and commercialization success
- Define and drive lifecycle management strategies to optimize product performance resource allocation and long-term value
- Provide leadership across complex multi-product or multi-site initiatives driving alignment and resolution of critical CMC challenges
- Guide decision-making on scientific and CMC matters balancing business priorities and technical considerations
- Collaborate across global MSAT manufacturing sites and external partners to deliver robust innovative solutions including digital and data-driven approaches
- Champion innovation in manufacturing processes technologies and analytics to enhance product quality and operational efficiency
- Foster a culture of collaboration quality and continuous improvement while influencing stakeholders across a global matrixed environment
What you bring to Takeda
- Degree in engineering life sciences or a related field (advanced degree preferred)
- Extensive experience (typically 10 years) in biologics development and manufacturing within the pharmaceutical industry
- Strong understanding of CMC regulatory expectations and lifecycle management for biologics
- Proven ability to lead complex cross-functional initiatives in a global matrixed organization
- Demonstrated strategic thinking with the ability to translate complexity into clear direction and actionable plans
- Strong leadership and influencing skills with experience driving alignment across diverse stakeholders
- Ability to navigate ambiguity and make sound decisions with significant business impact
- Analytical mindset with strong problem-solving capabilities and a track record of innovation
- Excellent interpersonal and communication skills with a collaborative and inclusive leadership approach
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:
Lexington MAU.S. Base Salary Range:
$177000.00 - $278080.00
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 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
Lexington MACHE - Glattpark (Opfikon) - Zurich HQ IRL - Dublin - Baggot StreetWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full 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.Required Experience:
Director
About Company
Takeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.