Head of Manufacturing Sciences, Athlone

About This Role:

In the role of Head of Manufacturing Sciences at the Athlone Site you will lead a dedicated team responsible for overseeing and advancing manufacturing process technology. As a pivotal member of the Site Leadership Team you will direct the broad responsibilities of the Manufacturing Sciences (MS) division ensuring the seamless technology transfer implementation of advanced process controls and ongoing manufacturing process monitoring. Your role will be crucial in providing essential technical support ensuring campaign success and maintaining an inspection-ready state for manufacturing processes. By representing the Athlone site on the Global Manufacturing Sciences Leadership Team (GMS LT) you will develop and align goals with both Athlone site and GMS objectives ensuring cohesive progress towards strategic imperatives.

This position requires working on site in Athlone for 5 days per week.

What Youll Do:

• Provide technical direction and leadership to staff and matrixed teams for seamless process integration and monitoring.

• Collaborate with site and global leadership teams providing strategic recommendations and ensuring alignment with global goals.

• Translate business priorities into tactical objectives for the site MS teams ensuring adherence to production schedules.

• Manage budget staffing and performance management while mentoring staff for career development.

• Ensure compliance with cGXP regulations and maintain high regulatory compliance supporting regulatory inspections.

• Foster a culture of innovation driving strategic priorities for technology and digital transformation at scale.
  

Who You Are:

You are a seasoned technical leader with deep expertise in sterile drug product manufacturing and a strong ability to operate at the interface of development and commercial operations. You thrive in complex crossfunctional environments bringing together teams across Quality Regulatory Engineering and Manufacturing to solve problems and deliver robust compliant processes. Youre a strategic thinker who can translate product and site priorities into clear technical plans while also being handson enough to troubleshoot issues lead validation activities and guide longterm improvements. Youre collaborative influential and confident engaging with regulators and youre motivated by the opportunity to build and shape a growing Manufacturing Sciences function.

Required Skills:

• MSc/PhD in a relevant scientific or engineering discipline with significant and proven years of experience in sterile/aseptic drug product manufacturing.

• Ability to act as the technical bridge between development and manufacturing aligning process needs with site capability and capacity

• Strong background in tech transfer process engineering MSAT or manufacturing sciences with proven ability to troubleshoot and optimise drug product processes.

• Experience developing strategies for validation campaigns ideally in a fastpaced or highthroughput environment.

• Experience hosting or presenting during regulatory inspections including responding to technical questions and supporting inspection strategy.

• Experience acting as a site technical authority for drug product knowledge/processes (e.g. material changes risk assessments and lifecycle management)

• Handson experience with drug product process troubleshooting deviation resolution and longterm corrective actions.

• Strong understanding of how to align site capacity equipment capability and process needs.

• Deep understanding of cGMP/cGXP requirements for sterile drug product manufacturing.

• Experience influencing senior stakeholders and contributing to sitelevel strategy