Operations Director, Drug Substance (Upstream)

We are excited to announce an opportunity for an Operations Director at our cutting-edge Biotech facility in Dublin. Here, we are dedicated to delivering life-changing medications to patients worldwide.

As a key member of our Site Leadership Team, you will help shape our site and organizational strategies. You will report directly to the Plant Manager/Site Head and play a vital role in our mission in delivering biologics medicines.

Bring energy, knowledge, innovation to carry out the following:

• Leadership in Manufacturing: Guide drug substance manufacturing for commercial production and new product introductions. Collaborate with teams to ensure smooth technology transfers.
• Team Development: Coach and empower operations personnel to become strong leaders. Address resource needs to maintain smooth operations and foster a culture of continuous learning.
• Collaboration and Partnership: Lead site and cross-functional teams to enhance collaboration and alignment across departments. Oversee Integrated Process Team deliverables alongside manufacturing responsibilities.
• Operational Excellence: Drive stability and efficiency in production using Lean and Six Sigma principles. Identify and implement process improvements.
• Quality Management: Ensure compliance with quality management systems, risk processes, and regulatory requirements. Lead inspection efforts and maintain readiness.
• Financial Management: Manage financial forecasts and departmental costs, ensuring alignment with capital and expense plans.
• Digital Transformation: Advocate for the use and implementation of digital tools to improve operational efficiency and stay updated on emerging technologies.
• Performance Accountability: Ensure timely delivery on site strategies (Hoshin Kanri) and key performance indicators, monitoring targets related to hiring, production, and operational availability.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Leadership and Communication: Strong ability to lead cross-functional teams and foster a high-performance culture while effectively communicating with stakeholders.
• Operational Excellence: Commitment to continuous improvement and familiarity with Lean, Six Sigma, and other operational excellence tools.
• Cross-functional Team Leadership: Proven track record in decision-making and leading teams to solve complex issues in a manufacturing environment.
• Influencing and Relationship Building: Expertise in building partnerships to drive collaboration and achieve key outcomes.
• Technical Competencies: Experience in manufacturing and technical operations leadership, particularly in upstream cell culture processes.
• Regulatory Knowledge: Understanding of global health authority regulations and good manufacturing practices for large molecule manufacturing, with experience engaging with regulatory agencies.

Minimum education and experience:

• A degree in Engineering, Science, Technical, or a related field.
• At least 8 years of leadership experience in a cross-functional environment, including direct or indirect people management.
• Experience in biotech, vaccines, or pharmaceutical manufacturing is preferred.