Process Development Product Lead

<h2><b>Career Category</b></h2>Process Development<h2></h2><h2><b>Job Description</b></h2><p><b><span>Product Lead (Repatha), Process Development</span></b></p><p><b><span>Amgen Dun Laoghaire – Dublin</span></b></p><p></p><p><b><span>Overview:</span></b></p><p><span>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 &amp; 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.</span></p><p></p><p><b><span>Key responsibilities</span></b></p><p><i><span>Product health stewardship and governance</span></i></p><ul><li><span>Act as the Product Health Steward for Repatha at ADL, owning product health through effective product governance and disciplined cross-functional leadership.</span></li><li><span>Lead and facilitate key Repatha project governance forums (e.g., team meetings, weekly/monthly product reviews) to ensure clear decisions, follow-up, and execution.</span></li><li><span>Ensure relevant site goals, network Governance Approved Baselines (GABs) and key governance decisions are translated into site action plans and prioritized appropriately.</span></li></ul><p></p><p><i><span>Lifecycle strategy and delivery</span></i></p><ul><li><span>Develop and maintain the site lifecycle management (LCM) program for Repatha, including scope definition, prioritization, and execution oversight across the product team.</span></li><li><span>Contribute to the long-term site product vision and strategy for Repatha, ensuring alignment with ADL strategy and network expectations.</span></li><li><span>Support new product/market introductions and Repatha SKU changes, coordinating readiness and execution across site functions.</span></li></ul><p></p><p><i><span>Network interface &amp; stakeholder leadership</span></i></p><ul><li><span>Serve as ADL’s primary point of contact for Repatha Global Operations Leads (GOLs) and Product Delivery Teams (PDTs).</span></li><li><span>Ensure ADL needs, constraints, and priorities are clearly articulated and appropriately represented in site and global governance.</span></li><li><span>Build and maintain strong working relationships with product/process knowledge SMEs at both site and network level.</span></li></ul><p></p><p></p><p><i><span>Risk management and technical transfer leadership</span></i></p><ul><li><span>Own the site product risk register for Repatha; proactively identify vulnerabilities/gaps and drive mitigation and remediation plans through the product team.</span></li><li><span>Provide process transfer technical leadership and decision-making on Tech Transfer/NPI project team and within Technology Development &amp; Transfer governance forums.</span></li><li><span>Influence site and above-site stakeholders to protect site strategy while meeting network commitments.</span></li></ul><p></p><p><span>Compliance and quality expectations</span></p><ul><li><span>Ensure all work is executed in alignment with cGMP, EHS, quality system requirements, and applicable business/financial controls.</span></li><li><span>Promote a culture of personal accountability, right-first-time execution, and proactive issue escalation.</span></li></ul><p></p><p><b><span>Skills and knowledge</span></b></p><ul><li><span>Strong matrix leadership capability: able to align cross-functional teams, drive decisions, and sustain execution without direct authority.</span></li><li><span>Solid understanding of development, manufacturing, validation, quality, regulatory, and product lifecycle management processes in a cGMP environment.</span></li><li><span>Demonstrated programme/project leadership skills (planning, risk management, governance, stakeholder alignment, and delivery tracking).</span></li><li><span>Clear, confident communication skills across site and global stakeholders; able to translate complexity into actionable decisions.</span></li><li><span>Strong interpersonal skills with demonstrated ability to influence, negotiate priorities, and manage competing demands.</span></li><li><span>Customer-focused, data-informed decision-making and strong prioritization skills across a dynamic portfolio.</span></li></ul><p></p><p><b><span>Qualifications</span></b></p><ul><li><span>Bachelor’s degree in a technical discipline required; Master’s degree or equivalent experience preferred.</span></li></ul><p></p><p><b><span>Experience</span></b></p><ul><li><span>5–7 years’ experience in biopharma/pharma (cGMP environment), with demonstrated leadership in manufacturing/technical operations and cross-functional delivery.</span></li><li><span>Working technical knowledge relevant to Repatha manufacturing and lifecycle execution (e.g., parenteral fill-finish and/or primary packaging/combination product interfaces, as applicable).</span></li><li><span>Track record identifying risks/gaps and implementing practical mitigation/remediation plans through cross-functional teams.</span></li><li><span>Demonstrated technical and/or program leadership experience, including translating objectives into integrated, measurable execution plans.</span></li><li><span>Strong process and manufacturing execution background.</span></li></ul><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.