Title:  Lead Pharma Manu PPM CMC

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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.

Working Environment and Location

• This position is based in the Dublin Plant and will require hybrid working (1-2 days a week in the office).
• Additional locations: Kerry facility
• This is a permanent position.
• This position requires some national and international travel.
• Collaboration across EU, US, and Japan time zones.
• 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.

Working Hours

• Full-time

Purpose and Scope

• This role is the single, accountable CMC Leader for assigned product(s), acting as the primary CMC interface to Astellas Ireland Co., Ltd. (AICL).
• This role defines and delivers globally aligned CMC strategy ensuring optimal formulation, manufacturability, supply reliability, and COGM.
• This position will also translate complexity into strategic options, risks, and business implications for AICL and governance decision-making.

Role and Responsibilities

• Define and implement an integrated global CMC strategy consistent with AICL product strategy and relevant strategic priorities.
• Serve as primary CMC representative to AICL and governance bodies.
• CMC representative on decision making bodies, such as the Asset Maximization Team (AMT) and AICL International Business Executive Management committee (AICL IB EM).
• Collaborates with AICL and applicable stakeholders in the development of product development and management proposals for approval, together with all key CMC updates for submission to AICL IB, EM, and Board.
• Lead formulation strategy including dosage form, stability, manufacturability, and lifecycle flexibility.
• Own COGM strategy including cost targets and optimization initiatives.
• Own CMC risk management including global risk register and mitigation strategies.
• Lead cross-functional CMC matrix team across EU, US, and Japan.

Continue:Role and Responsibilities

• Ensure delivery of CMC milestones, regulatory submissions, and supply readiness.
• Drive proactive lifecycle management including product innovation, process improvements and supply optimization.
• Co-lead regulatory strategy and ensure compliant submissions.
• Manage budgets, forecasts, and trade-offs between cost, timelines, and risk.
• Translate and communicate strategy, risks, and value to senior stakeholders.

Essential Qualifications

• Advanced degree in pharmaceutical sciences, chemistry, or engineering.
• Significant proven CMC experience across development and/or commercial operations.
• Significant Project and Product Management experience
• Experience leading global, cross-functional matrix teams.
• Broad expertise in formulation, manufacturing, regulatory, and supply strategy.
• Experience with COGM optimization and lifecycle management.
• Strong business acumen including financial modelling and ROI evaluation.
• Knowledge of GMP and global regulatory requirements.

Preferred Qualifications

• Experience supporting entity-based product oversight models such as AICL.
• Experience aligning global and regional CMC organizations (EU, US, Japan).
• Experience managing CDMOs and external partners.

Benefits

Careers | Astellas

Why 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 Organisational Values and Behaviours

Skills and Capabilities

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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.