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

Closing Date