Vice President, Technical Operations

Vice President, Technical Operations
Location: Dublin , Ireland

We are seeking an exceptional and experienced Vice President to lead our Technical Operations division at Alexion Rare Disease. This pivotal role will be expected to provide global strategic leadership, aligning with the company's mission and goals, and partner with senior leaders both within the Rare Disease Unit within AstraZeneca and within the sector to ensure technical decisions enable strategy. They will drive flawless product launches, robust manufacturing processes, next generation process improvements, lead technical investments, and step change for COGs specific improvement. The VP will be responsible for building out new capabilities in Manufacturing Systems, Cell and Gene Therapy, Combination Devices and ADCs. In addition, they will lead the Capital investment program from the client perspective across Operational units globally.

You will be responsible for:

Provide global strategic leadership and vision for the Technical Operations division, aligning with Alexion Rare Disease's mission and goals.

Develop the Tech Ops organization to be best in class ensuring strong leadership and development pathways for key technical talent at all levels in the organization including a focus on fostering a culture of continuous improvement, agility, and adaptability, aligned with the rapid advancements in pharma manufacturing technologies

As the Ireland Campus expands ensure Tech Ops can support all technologies and manufacturing/lab technologies both resident in the Ireland Campus and managed by Alexion Ops globally.

Build out a technical capability within Tech Ops to meet the needs of the future product portfolio including Large Molecule, Small Molecule, Peptides, ADCs, Combination Products and Cell and Gene Therapy

Partner with senior leaders across different functions within Alexion Rare Disease and Astra Zeneca Operations, such as Research & Development, Quality Assurance, Regulatory Affairs, and Commercial Operations, aligning technical decisions with the broader organizational strategy. Ensure adherence to evolving regulatory standards globally, as well as driving robust risk management practices to strengthen operational resilience.

Ensure flawless launches with robust manufacturing processes by partnering with R&D during product development cycles, and lead network maturity to improve global network performance on par with best in class in the industry

Partner with manufacturing site Leaders across the internal and external network in Dublin, Athlone, and Bogart and CMOs to implement best practices for network-wide adoption and drive product-specific improvement to improve Cost of Goods and Robustness of our Products.

Set COGS Improvement goals and drive to these targets via step change and incremental cost efficiencies. Improve overall operational performance on a global scale

Develop Manufacturing/Quality Systems and Analytics capability to make better decisions, drive efficiencies and in-bed agility and flexibility into our production of the future. Specifically focusing on:

• Predictive Analysis
• SMART Manufacturing
• Operations Reporting
• Digital Twin
• Electronic Batch Records
• Automation/MES & predictive instrumentation

Constantly strive to innovate at a product and technology level, looking to step to next generation within 3 years of launch.

Build out a Tech Transfer capability to transfer products internally, externally and into regions that benefit commercial strategies. Collaborate both internally and externally with our CMOs to release capacity via Tech Transfer Strategy.

Evolve to a centralized manufacturing support capability, driving performance excellence and synergies across multiple manufacturing units including

• Process Engineering
• Validation & Reg Mgt.
• Tech Transfer
• Analytical Analysis
• Product Investigations
• MSAT

Build out a master plan for the Ireland sites including investment options. Foster forward looking thinking while engaging with key stakeholders to communicate the strategy.

Oversee the planning, execution, and control of large-scale capital projects related to facility expansion, equipment acquisition, and technology upgrades, ensuring on-time and on-budget delivery. Collaborate with cross-functional teams to align project investments with the organization's strategic objectives and operational needs

Establish a cell and gene therapy capability within operations from zero base to active product introduction in next 5 years. Manage the transfer and scale-up of cell and gene therapy processes from research to commercialization, ensuring seamless integration and optimization.

Engaging with external stakeholders, including regulatory agencies, industry partners, and patient advocacy groups, in alignment with the organization's public relations and corporate social responsibility strategies.

Develop & Lead the implementation of sustainability strategies and initiatives that align with AstraZeneca's environmental goals, driving sustainable operations, reducing environmental impact, and ensuring compliance with environmental standards.

Drive programs and initiatives that address health disparities and promote health equity within the workplace and in the communities where RDU operates. Collaborate with internal and external stakeholders to promote EHS, sustainability, health equity, and I&D initiatives, building partnerships and engaging with employees, communities, and regulatory agencies.

Foster a culture of collaboration, innovation, and accountability within the Technical Operations team, promoting diversity, equity, and inclusion, and aligning with Alexion Rare Disease's values and mission.

You will need to have:
•Master's or PhD degree in a relevant scientific, engineering, or chemistry discipline
•Minimum of 20 years of progressive leadership experience in global pharmaceutical or biotech Technical Operations
•Proven track record of success in driving global operational excellence and compliance with international regulatory requirements
•Expertise in cell therapy and gene therapy, as well as knowledge in regulatory affairs CMC, immunology, biologics, and CAR T-cell therapies
•Strategic thinker with a deep understanding of international regulatory requirements, cGMP guidelines, and industry standards
•Excellent communication skills, with the ability to influence and collaborate at all levels of the organization on a multinational scale
•Demonstrated leadership capabilities, with a focus on fostering diverse, inclusive, and high-performing teams aligned with Alexion Rare Disease.