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- Dublin Overview: The Product Lead (Repatha), Process Development is accountable for end-to-end product health stewardship and lifecycle delivery for Repatha at ADL.Reporting to the Sr.Manager, Process Development within the Product Portfolio Delivery (Syringe) team (Portfolio Management & Delivery), this role leads a cross-functional product team in a matrix organization to deliver technology transfers/new introductions and lifecycle management initiatives, while ensuring robust product governance, risk management, and alignment between site priorities and network demands.Key responsibilities Product health stewardship and governance Act as the Product Health Steward for Repatha at ADL, owning product health through effective product governance and disciplined cross-functional leadership.Lead and facilitate key Repatha project governance forums (e.g., team meetings, weekly/monthly product reviews) to ensure clear decisions, follow-up, and execution.Ensure relevant site goals, network Governance Approved Baselines (GABs) and key governance decisions are translated into site action plans and prioritized appropriately.Lifecycle strategy and delivery Develop and maintain the site lifecycle management (LCM) program for Repatha, including scope definition, prioritization, and execution oversight across the product team.Contribute to the long-term site product vision and strategy for Repatha, ensuring alignment with ADL strategy and network expectations.Support new product/market introductions and Repatha SKU changes, coordinating readiness and execution across site functions.Network interface & stakeholder leadership Serve as ADL's primary point of contact for Repatha Global Operations Leads (GOLs) and Product Delivery Teams (PDTs).Ensure ADL needs, constraints, and priorities are clearly articulated and appropriately represented in site and global governance.Build and maintain strong working relationships with product/process knowledge SMEs at both site and network level.Risk management and technical transfer leadership Own the site product risk register for Repatha; proactively identify vulnerabilities/gaps and drive mitigation and remediation plans through the product team.Provide process transfer technical leadership and decision-making on Tech Transfer/NPI project team and within Technology Development & Transfer governance forums.Influence site and above-site stakeholders to protect site strategy while meeting network commitments.Compliance and quality expectations Ensure all work is executed in alignment with c GMP, EHS, quality system requirements, and applicable business/financial controls.Promote a culture of personal accountability, right-first-time execution, and proactive issue escalation.Skills and knowledge Strong matrix leadership capability: able to align cross-functional teams, drive decisions, and sustain execution without direct authority.Solid understanding of development, manufacturing, validation, quality, regulatory, and product lifecycle management processes in a c GMP environment.Demonstrated programme/project leadership skills (planning, risk management, governance, stakeholder alignment, and delivery tracking).Clear, confident communication skills across site and global stakeholders; able to translate complexity into actionable decisions.Strong interpersonal skills with demonstrated ability to influence, negotiate priorities, and manage competing demands.Customer-focused, data-informed decision-making and strong prioritization skills across a dynamic portfolio.Qualifications Bachelor's degree in a technical discipline required; Master's degree or equivalent experience preferred.Experience 5-7 years' experience in biopharma/pharma (c GMP environment), with demonstrated leadership in manufacturing/technical operations and cross-functional delivery.Working technical knowledge relevant to Repatha manufacturing and lifecycle execution (e.g., parenteral fill-finish and/or primary packaging/combination product interfaces, as applicable).Track record identifying risks/gaps and implementing practical mitigation/remediation plans through cross-functional teams.Demonstrated technical and/or program leadership experience, including translating objectives into integrated, measurable execution plans.Strong process and manufacturing execution background.To be considered for this role you will be redirected to and must complete the application process on our careers page.
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