Manufacturing Operations Manager - Lyophilisation

(2491) Genzyme Ireland Limited; 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

Job Title: Manufacturing Operations Manager - Lyophilisation

Location: Waterford, Ireland

Job Type: Permanent, Full-time

Work Arrangement: On-site

About the role

Reporting directly to the Head of Lyophilisation Operations and as a leader for Sanofi, you will play an integral role within the Lyophilisation Autonomous Production Unit management team, ensuring reliable supply of lyophilised vial products for our rare disease patients globally. Ready to get started? Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main 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

About You

• 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

It would be advantageous to have (not essential): Sterile Operations experience in sterile filling and lyophilisation cGMP experience in a management position

Why choose us?

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
• Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day, with pride.
• Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever.
• Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science.
• But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

The salary range for this position is :€84 000,00 - €112 000 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors.

Employees may be eligible to participate in Company employee benefit programs.

We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.