Are you ready to lead on the manufacturing floor and help shape a new, state-of-the-art biologics facility from day one? At our new bulk drug substance site in College Park, Dublin, you will bring senior-level expertise to an empowered shift team producing high-quality biologics for patients with urgent, unmet needs. In this senior, hands-on role, you will set the standard for technical excellence, operational discipline, and continuous improvement. You will help build a manufacturing culture that delivers right-first-time execution through advanced automation, electronic batch records, and data-led decisions. Can you see yourself stepping in as the go-to decision maker, guiding colleagues across functions, and turning process data into actions that improve yield, robustness, and speed? Accountabilities: End-to-End Unit Operations: Independently execute core tasks across cell culture, media preparation, purification, buffer preparation, and ancillary activities including equipment preparation to deliver safe, compliant, and reliable supply. Shift Leadership and Decision-Making: Act as designee for the shift lead, making effective, timely decisions across interdependent operations and maintenance activities to protect schedule adherence and product quality. Technical Subject Matter Expertise: Develop and demonstrate specialisms across multiple process technologies; act as the go-to expert for troubleshooting and optimization. Digital Systems and Automation: Operate and optimize manufacturing control systems and electronic records (e.g., MCS, SAP, electronic batch records) to drive accuracy, compliance, and transparency. Data-Driven Improvement: Gather and analyze process and operational performance data; lead initiatives that reduce deviations, cycle time, and waste while improving yield and robustness. Continuous Improvement Champion: Use Lean tools (Standard Work, 5S, Method 1/2) to embed zero-defect thinking and elevate daily performance across shifts and functions. Documentation and Compliance: Execute work to SOPs and batch records (paper and electronic) with meticulous attention to detail in a cGMP environment. Deviation and Investigation Support: Perform initial issue triage; contribute to investigations through the quality tracking system, collaborating with all relevant functions to identify root cause and implement CAPAs. Training and Knowledge Transfer: Mentor colleagues in SOPs, process execution, and equipment operation; elevate team capability and consistency of execution. SOP and Record Ownership: Provide input into the creation and maintenance of area SOPs and batch records to reflect best practice and regulatory expectations. Start-up, Tech Transfer, and Validation: Support facility and equipment start-up activities; provide input on installation, commissioning, operation, and troubleshooting to introduce new products into sustained operations. Safety and Housekeeping: Maintain a safe, inspection-ready workplace at all times; proactively identify and address hazards. Equipment and Materials Readiness: Partner with maintenance and materials teams to ensure equipment availability and correct materials consumption in SAP to protect batch flow. Shift Operations: Work a rotating shift pattern that includes weekends and periodic day/night rotations; adapt to changing business needs while maintaining performance. Essential Skills/Experience: Proven technical leadership and complex decision-making abilities in a biotech operating environment. Must be able to work within and adapt to complex electronic systems such as process automation, SAP, and Trackwise investigation system. Must have in-depth knowledge of biotech manufacturing processes and their translation into documentation such as batch records and SOPs. Must be familiar with biopharmaceutical equipment and systems such as bioreactors, centrifuges, autoclaves/glass washers, media/buffer systems, and purification systems. Knowledgeable of current Good Manufacturing Practices (cGMPs) and regulatory requirements. Must possess strong verbal and written communication skills. Requires 8+ years’ experience in a cGMP biotech manufacturing environment. BA/BS in a scientific field or equivalent experience preferred. Desirable Skills/Experience: Accountability: Holds self and others accountable for delivering results and puts patients first. Decision Quality: Considers all relevant factors and uses appropriate decision-making criteria and communicates these appropriately. Collaboration: Champions open dialogue and communication. Cultivates Innovation: Can take a creative idea and put it into practice. Perspective: Looks toward the broadest possible view of an issue/challenge. Planning: Accurately scopes out length and difficulty of tasks and projects. Problem-solving: Uses rigorous logic and methods to solve difficult problems with effective solutions. Drive for results: Can be counted on to exceed goals successfully. Time Management: Can attend to a broad range of activities. Why AstraZeneca: Join a team advancing the frontier of rare disease biologics with the speed of a biotech and the strength of a global organization. You will help stand up a cutting-edge facility where advanced digital systems, powerful analytics, and modern bioprocessing come together to deliver medicines that change lives. Expect unexpected teams in the same room unleashing bold thinking, a culture that values kindness alongside ambition, and the chance to shape how a new site operates—from daily standards to long-term capability—so your impact reaches patients and colleagues across the world. Call to Action: If you are ready to lead on the floor, build something new, and deliver life-changing medicines with precision and purpose, step forward and make your mark today! Date Posted 15-Oct-2026 Closing Date 25-Oct-2026 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. For over three decades, patients and their caregivers have been at the center of everything we do. Every day, we are inspired to follow the science and think differently to create better outcomes for them and their families. Our mission is driven by understanding who they are as unique individuals, not solely defined by their diseases. We’re a leading rare disease company with a diversified projects. Our pioneering legacy in rare diseases is rooted in being the first to translate the complex biology of the complement system into transformative medicines over the past three decades. Today, we continue to push the boundaries of science and deepen our understanding of rare diseases with patient-centricity at the core. This knowledge allows us to innovate and evolve into new areas where needs are unmet and provide an opportunity to help people fully live their best lives.

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