Key Skills

Job Description

About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com. Are you driven to make a real difference in the lives of patients? We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact. Location and Working Environment This position is hybrid and will require you to be onsite 2 days per week in our Leiden, Netherlands office. Astellas’ Responsible Flexibility Guidelines Statement- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Purpose & Scope This role operates within a cross-functional Asset Maximization Team and is accountable for the CMC activities supporting the end-to-end advancement and value maximization of one or more strategic assets, from development candidate nomination through product registration, major product launch, and lifecycle transition. The CMC Leader serves as the single, integrated voice for CMC product development, manufacturing, and supply within the Asset Maximization Team. The role also contributes to shaping asset strategy, driving alignment across assets and with enterprise goals, and ensuring high-quality execution across product research and development, manufacturing, regulatory, quality, supply chain, commercial, finance, and external partner workstreams. The role translates scientific, technical, operational, and business complexity into clear strategic options, risk-based recommendations, and executable plans that maximize patient impact, portfolio value, and speed of decision-making. Role and Responsibilities Own and drive the integrated CMC asset strategy across the product lifecycle, ensuring alignment with the target product profile, clinical development, regulatory, commercial, launch, quality, and lifecycle objectives while maximizing product value and profitability. Serve as the lead CMC representative on cross-functional asset teams, providing strategic input to governance, investment decisions, innovation opportunities, and asset plans, while translating complex scientific, technical, quality, regulatory, manufacturing, and commercial considerations into clear recommendations. Lead integrated execution and delivery by directing cross-functional Product Value Teams, developing integrated CMC plans, managing budgets and resources, overseeing manufacturing site selection, and ensuring effective risk management and control strategies. Ensure regulatory, quality, and technical excellence through partnership with CMC Regulatory and other functions, co-developing regulatory strategies, supporting health authority interactions, and maintaining high-quality, compliant CMC submissions and filing strategies. Drive stakeholder alignment and governance, acting as the primary CMC interface with senior leadership, governance bodies, alliance partners, suppliers, and regulators, facilitating decision-making, resolving cross-functional risks, and ensuring consistent execution. Build organizational capability and team effectiveness by mentoring team members, promoting high standards of governance, quality, and value creation, and supporting the growth and development of colleagues contributing to asset and product outcomes. Required Qualifications Advanced degree in sciences, engineering, pharmaceutical sciences, or a related discipline or equivalent. Extensive experience in drug development and strategic asset leadership, including leading complex global matrix organizations. Proven leadership in product development, CMC, enterprise programs, or asset management, with accountability for strategy, execution, budgets, governance, and cross-functional outcomes. Broad end-to-end development expertise, including CMC, clinical development, regulatory affairs, manufacturing, quality, supply chain, commercialization, launch readiness, and lifecycle management. Strong business, financial, and strategic acumen, including competitive landscape assessment, investment decisions, resource prioritization, value optimization, and business development/partnership management. Outstanding leadership and influencing skills, with experience engaging senior executives, governance bodies, health authorities, external partners, CDMOs, vendors, and strategic alliances in complex environments. What awaits you at Astellas? Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide. Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day. Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare. A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions. Our Organizational Values and Behaviors Impact Innovation Integrity One Astellas Accountability Courage Sense of Urgency Outcome Focus Benefits Careers | Astellas We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.

Core Responsibilities

The CMC Lead is responsible for driving the integrated CMC asset strategy across the product lifecycle, serving as the primary CMC representative on cross-functional teams. They oversee manufacturing, regulatory, and supply chain workstreams to ensure high-quality execution and value maximization for strategic assets.

Requirements

Candidates must hold an advanced degree in sciences, engineering, or pharmaceutical sciences and possess extensive experience in drug development and strategic asset leadership. The role requires broad end-to-end development expertise and strong business acumen to manage complex global matrix organizations.

Benefits

• Hybrid working solution
• Work/life balance