Operations Manufacturing Team Leader

Job title: Operations Manufacturing Team Leader

• Location:Waterford, Ireland 

About the job

As a Manufacturing Operations Team Leader, you play a critical operational leadership role within Lyo Operations, driving end-to-end batch release performance, deviation management, and cross-functional collaboration across internal teams and external stakeholders supporting Rare Disease, Rare Blood Disorder, and General Medicines.

To provide leadership to their Production Team in the manufacture of products, in compliance with Quality & Safety guidelines.

You act as the central coordination point across all functions involved in the operational support process. While you are not directly accountable for the performance of other departments, you are responsible for establishing and maintaining the governance framework that enables each function to meet its commitments. This includes identifying performance gaps, escalating risks, and driving corrective actions where required.

Main responsibilities:

• Manage the manufacturing areas to ensure that production objectives are met
• Ensure production of products are undertaken in compliance with cGMP and Safety standards through regular walk through and review of deviations and GMP documentations
• Ensure staff for which they are responsible are trained against SOPs and GMP requirements relevant to their job
• Ensure procedures are correctly defined and followed
• Monitor the level of GMP compliance in their area on an on-going basis
• Assess the effectiveness of training on a regular basis
• Actively promote good housekeeping and hygiene practices
• Ensure problem solving reports are resolved in a timely manner
• Ensure all quality documentation and records are complete and current
• Train/assess competence for Team Member as required
• Manage performance of Team Member and overall team on an on-going basis
• Ensure that all production activities are organized and executed in compliance with cGMP and in compliance with the associated documentation
• Involved in the preparation, review and approval of Manufacturing documentation and records.
• Approval and implementation of changes to relevant systems and assist in validation / revalidation programmes.
• Provide support and backup to team members
• Define team targets / goals and support team in achieving them especially in the areas of safety, productivity and quality.
• Actively contribute to continuous improvement initiatives.

About you

Required Experience & Capabilities:

• Degree in Life Sciences, Engineering, Pharmacy, or a related discipline
• Significant experience in a biopharmaceutical or pharmaceutical manufacturing environment, with direct exposure to batch release and/or quality operations
• 3 – 5 years’ experience as a team leader / supervisory role
• 1 - 2 years’ experience of sterile manufacturing / aseptic processing
• Technical knowledge of manufacturing
• Proven track record in delivering Continuous improvement / Lean initiative programmes
• Leader who Delivers through collaboration
• Detailed knowledge of cGMP
• Excellent interpersonal skills – active listener
• Good problem solving and analytical skills
• Effective facilitator
• Understands site KPI’s
• Full understanding of Health & Safety and legal requirements for the safe operation of his team

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team 
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally 
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact 
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave 

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