An exciting opportunity has arisen for an experienced Lead Manufacturing Biotech Associate to join the our clients manufacturing team at Dunboyne Biologics.
This is a key role within the manufacturing organisation, offering the opportunity to take ownership of suite operations, provide technical leadership, support batch progression, and drive continuous improvement in a highly regulated biopharmaceutical environment.
Reporting to the Downstream Shift Lead, the Lead Manufacturing Biotech Associate will act as the senior operational point of contact within the shift suite. You will work closely with the Manufacturing Shift Lead, Shift Engineer, and self-directed work teams to ensure manufacturing activities are delivered safely, compliantly, and in line with the production schedule.
What You’ll Do
As a Lead Manufacturing Biotech Associate, you will:
- Lead the production of biologic drug substance within your designated manufacturing area.
- Act as a technical SME and key point of contact for colleagues during shift operations.
- Take ownership of batch progression and communicate progress, risks, and issues to the Manufacturing Shift Lead.
- Troubleshoot manufacturing issues and lead structured problem-solving activities.
- Support and lead self-directed work teams within the processing area.
- Operate automated manufacturing recipes using paperless manufacturing technology.
- Perform filtration and purification operations in accordance with GMP and EHS requirements.
- Set up single-use equipment between manufacturing runs.
- Ensure manufacturing activities are completed safely, compliantly, and to the required quality standards.
- Identify and implement opportunities for process improvement using Lean and continuous improvement methodologies.
- Coach and mentor colleagues and support the training and development of new employees.
- Lead and support approved manufacturing projects and continuous improvement initiatives.
- Maintain high standards across the manufacturing area and promote a strong culture of safety, quality, and compliance.
- Act as the primary delegate for the Manufacturing Shift Lead during emergency situations.
- Work collaboratively across site teams to resolve issues and ensure delivery against site commitments.
What You’ll Bring
We are looking for an experienced biopharmaceutical professional with strong technical and leadership capabilities.
You will have:
- A minimum Level 8 Bachelor's degree in a technical, engineering, scientific discipline, or equivalent qualification.
- At least 5 years' experience within the biopharmaceutical industry.
- Proven experience working within a GMP-regulated manufacturing environment.
- Strong understanding of cGMP, biologics manufacturing, and technical operations.
- Demonstrated leadership capability and experience delivering results through a team environment.
- Strong troubleshooting, analytical, and problem-solving skills.
- The ability to remain proactive, logical, and composed when working under pressure.
- Excellent communication and interpersonal skills.
- The ability to work effectively both independently and as part of a multidisciplinary team.
- A strong commitment to safety, quality, compliance, and continuous improvement.
- Flexibility to work a 24/7 shift pattern in a site-based manufacturing environment.