Director, Technical Services and Validation

Job Title: Director, Technical Services and Validation

Introduction to role:
Are you ready to lead and innovate in a dynamic environment? As the Director of Technical Services and Validation, you'll play a pivotal role in managing technical support for Drug Product and Biologics manufacturing at the Alexion Athlone Manufacturing Facility. This leadership role is crucial for supervising technology transfer, process scale-up, validation, and fixing issues, guaranteeing smooth operations for both commercial and clinical products. You will serve as the primary contact for global Process Development and Clinical Supply teams, leading new product introductions and championing multi-functional partnerships to improve daily operations.

Accountabilities:
• Accountable for new product introductions and technical support at the Athlone site.
• Lead process design and scale-up for new products.
• Ensure Site Validation compliance for Manufacturing Equipment, HVAC Systems, Clean Utilities, and Clean gases.
• Oversee Commissioning Qualification and Validation (CQV) activities.
• Provide technical leadership for process validation programs.
• Author technical documents for regulatory submissions.
• Lead process monitoring and statistical analysis of manufacturing operations.
• Drive process optimization initiatives for efficiency improvements.
• Support strategic plans for process and plant improvements.
• Ensure alignment with current regulatory requirements.
• Lead site preparation for regulatory inspections from a Validation perspective.
• Develop Risk Based Verification processes for the site.
• Provide Sterility Assurance Oversight and Cleaning Validation compliance.

Essential Skills/Experience:
• Minimum of 8-10 years’ experience in Manufacturing, Technical Services or Validation in a biopharmaceutical manufacturing organization, with expertise in Biologics and liquid fill operations.

Experience completing technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically drug substance and sterile liquid fill operations
• Experience with design, commissioning, qualification or validation of a drug product facility.
• Proficient knowledge of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement standard methodologies to ensure multi-product drug manufacturing operations are cGMP compliant.
• Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.

Desirable Skills/Experience:
Degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field. Advanced degree (MS, PhD) preferred.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, you'll find an environment where innovation thrives! Our commitment to patients drives us to push boundaries in R&D and healthcare. With a rapidly expanding portfolio, you'll enjoy the entrepreneurial spirit of a leading biotech combined with the resources of a global pharma. Here, your career is not just a path but a journey where you can make a real difference. Supported by exceptional leaders and peers, you'll be empowered to grow your skills and explore new ideas.

Ready to take the next step in your career? Apply now to join our team!

Date Posted

17-Jul-2025

Closing Date

13-Aug-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.