An exciting opportunity has arisen for an experienced Lead Manufacturing Biotech Associate to join a leading biopharmaceutical manufacturing facility in Co. Meath.
This is a key leadership position within the Downstream Manufacturing Operations team, offering the opportunity to take ownership of manufacturing activities, drive batch progression and provide technical expertise across the production suite.
Reporting to the Downstream Shift Lead, you will act as the senior member of the shift operations team, ensuring manufacturing schedules are delivered safely, efficiently and in full compliance with cGMP and EHS requirements.
You will play a pivotal role in troubleshooting operational challenges, coaching and developing team members, supporting continuous improvement initiatives and ensuring right-first-time execution across all manufacturing activities.
Key Responsibilities
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Lead and coordinate day-to-day downstream manufacturing operations to ensure successful batch progression and delivery against production schedules.
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Act as the primary technical point of contact within the manufacturing suite, providing guidance, coaching and support to colleagues.
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Liaise closely with the Manufacturing Shift Lead and Shift Engineer to ensure operational targets and commitments are achieved.
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Lead troubleshooting and problem-solving activities, identifying issues and implementing effective solutions to minimise operational disruption.
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Execute automated manufacturing recipes using paperless manufacturing technologies across filtration and purification processes.
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Oversee the setup and preparation of single-use equipment between manufacturing runs.
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Ensure all manufacturing activities are performed in accordance with cGMP, EHS requirements and site procedures.
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Drive operational excellence through standard work, lean manufacturing principles and continuous improvement initiatives.
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Support the training, mentoring and development of new and existing employees.
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Lead and support approved projects and improvement initiatives aligned with site objectives.
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Maintain high standards of housekeeping, safety, compliance and operational readiness within the manufacturing area.
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Act as the primary delegate for the Manufacturing Shift Lead during emergency situations.
Skills & Experience Required
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Minimum Level 8 Bachelor's degree in a relevant scientific, engineering or technical discipline, or equivalent.
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At least 5 years' experience within the biopharmaceutical manufacturing industry.
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Demonstrated leadership experience, with the ability to motivate, coach and develop team members.
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Strong understanding of current Good Manufacturing Practices (cGMP) and regulated manufacturing environments.
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Practical knowledge of biologics manufacturing and downstream processing operations.
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Proven troubleshooting and problem-solving capabilities.
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Experience with filtration, purification and single-use technologies would be advantageous.
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Ability to work independently, use initiative and make effective decisions under pressure.
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Strong communication and interpersonal skills, with the ability to work collaboratively across multidisciplinary teams.
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A proactive approach to safety, quality, compliance and continuous improvement.
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Flexibility to work a site-based 24/7 shift pattern.
