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
#LI-EUR
Salary description
£54800.00 - £73067.00 per year