Process Development Product Lead

Product Lead (Repatha), Process Development

Amgen Dun Laoghaire – 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 cGMP, 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 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; 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 (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.