Lyophilisation Manufacturing Operations Leader

Sanofi Group; Waterford; On-site; EUR 84,000 - 112,000; Full time

Job summary

Sanofi Group in Waterford, Ireland is seeking a Manufacturing Operations Manager - Lyophilisation to lead the Lyophilisation Autonomous Production Unit. You will ensure reliable supply of lyophilised vial products for rare disease patients, while driving safety, quality and continuous improvement across the site.

The role requires extensive experience in pharmaceutical manufacturing, strong leadership, and deep knowledge of cGMP and sterile filling processes. On-site work with global impact.

Qualifications

• Essential requirements: Higher level Diploma/Degree in Third level qualification or equivalent.
• Significant experience as an Operations Manager/other Management role.
• Significant experience of pharmaceutical manufacturing environment.
• Technical knowledge of relevant sterile filling and lyophilisation technology.
• Detailed knowledge of cGMP regulations.
• Good problem solving and analytical skills.
• Effective facilitator & Excellent interpersonal skills.
• Influences site KPI’s and drives area improvement.
• Full understanding of Health & Safety and legal requirements for the safe operation of his team.

Responsibilities

• Lead all assigned operations activities to ensure that objectives are met; batch filling & Lyophilisation (Loading/unloading), batch turnaround time, batch release cycle time, annual planning, project/program implementation, CI plans, etc
• Ensure all activities are undertaken in compliance with cGMP (FDA 21 CFR Part 211, EU GMP Annex 1) and Safety standards
• Ensure all employees, 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 through audit, deviations and GMP document reviews
• Develop and improve the effectiveness of training on a regular basis
• Develop and lead a continuous improvement program that will result in savings to COGs

Skills

Operations management

Leadership

Problem solving

Analytical skills

Education

Higher level Diploma/Degree

Tools

Sterile filling systems

Lyophilisation technology

cGMP knowledge

Job description

Sanofi Group in Waterford, Ireland is seeking a Manufacturing Operations Manager - Lyophilisation to lead the Lyophilisation Autonomous Production Unit. You will ensure reliable supply of lyophilised vial products for rare disease patients, while driving safety, quality and continuous improvement across the site.

The role requires extensive experience in pharmaceutical manufacturing, strong leadership, and deep knowledge of cGMP and sterile filling processes. On-site work with global impact.