Our client is a global leader in the biotech industry sector with expanding operations both global and here in Ireland. They are seeking an experienced manufacturing professional to lead their production operations at their new state of the art biologics drug substance manufacturing facility. The site is currently at green field stage with ambitious timelines to manufacturing ready.

The Role

• Reporting to the Site Lead, the Senior Director of Operation's will be directly responsible for managing the manufacturing function to ensure it has the capacity, capability and leadership structures in place to deliver the site manufacturing plan.
• You will be responsible for leading the integration of the cross functional management team that provides functional support to manufacturing operations.
• You will be a key member of the site senior leadership team with collective responsibility to develop and implement the strategic direction, organizational capability and management of the site.
• You will play a key team role in driving the site toward achieving long term business objectives, continuously developing the organisation for the future while taking consideration for corporate objectives and changing external environments.
• Alongside the leadership team, you will play your part to build a completely new organisation while developing and implementing the necessary SOPs required to support GMP operations.
• The Senior Director of Operations will build and develop a site culture to operate the facility to the highest standards of excellence.
• You will develop systems and processes leveraging the already existing knowledge within the network where necessary while incorporating external experiences and learning.
• Supporting the project team to deliver the facility to you as the end user, while providing feedback and support on design decisions, commissioning strategies and other key decisions. Collaborating with them to ensure the right decisions are made to meet project deliverables and long-term strategic goals for the site.

Once the site is established, you will be responsible for developing the strategic and operational plans for production operations with responsibility for the execution of these plans.

• Ensuring manufacturing operations remain compliant with all applicable regulatory requirements.
• You will ensure the production flow team and process teams meet expectations prescribed by the organisation's standards.
• Ensuring a robust control system exists across the manufacturing function, escalating any issues appropriately.
• You will review the site and business area performance regularly and take corrective action as appropriate when needed.
• Through leadership of the cross functional management support team, you will be responsible for implementation of NPIs and continuous improvement opportunities.
• You will coach, mentor and develop future management and technical leadership for both the site and global network.

The Person

• You will be an ambitious leader with over 10 years' experience in a leadership role within the pharmaceutical/ biotech industry sector.
• Experience in biologic drug substance is preferred, however a combination of experience and/or education will be taken into consideration.
• You will have a strong understanding of cGMNPs and how they apply to a biotech manufacturing position.
• Must have a strong ability to form effective relationships at all levels.
• You will have a demonstrated track record of successfully developing, managing and executing projects from start to finish on time and within budget.
• Experience in developing and managing talented, engaged and high performing teams with a focus on building strong cultures for a safe and successful working environment.

The Benefits

• Full health cover.
• Pension.
• Bonus.
• Stocks.

To learn more, apply online or contact Ciaran McCaughey on +353 1 6321830 or please submit an updated CV.