CMC Lead, Launch Product, Biologics (Director)

Takeda • Lexington, MA

2d • Onsite

About The Position

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 Takeda’s biologics portfolio on a global scale. You will report into the Head of MSAT Biologics.

Requirements

• 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

Responsibilities

• 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

Benefits

• 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
• well-being benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Director