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Process Development Product Lead

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Amgen

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Location:
Ireland , Dun Laoghaire

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

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Job Description:

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.

Job Responsibility:

  • 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
  • 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
  • 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
  • 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
  • Ensure all work is executed in alignment with cGMP, EHS, quality system requirements, and applicable business/financial controls
  • Promote a culture of personal accountability, right-first-time execution, and proactive issue escalation

Requirements:

  • Bachelor’s degree in a technical discipline required
  • Master’s degree or equivalent experience preferred
  • 5–7 years’ experience in biopharma/pharma (cGMP 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
  • Strong matrix leadership capability
  • Solid understanding of development, manufacturing, validation, quality, regulatory, and product lifecycle management processes in a cGMP environment
  • Demonstrated programme/project leadership skills (planning, risk management, governance, stakeholder alignment, and delivery tracking)
  • Clear, confident communication skills across site and global stakeholders
  • 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

Additional Information:

Job Posted:
March 04, 2026

Work Type:
Hybrid work
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