Manufacturing Technologies & industrialisation Manager
About the Opportunity
You will be responsible for the introduction of new products onsite and leading a team to ensure products are transferred from external and internal line to line in a timely manner.
About the Sanofi Business Unit
The Sanofi Waterford biopharmaceutical and medical device campus is located in Waterford on Ireland’s southeast coast. Established in 2001 and now with more than 700 employees, the multiple national award-winning site has seen more than €600m invested in state-of-the-art infrastructure and technology. Diversification continues to bring new products to Waterford and the expanded site portfolio continues to create new opportunities. Sanofi is a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
About growing with us
- Build process engineering capability in aseptic fill finish and lyophilisation technologies and develop SME capability across the site’s Drug Product technology platforms.
- Ensure the site keeps abreast of technology enhancements to ensure manufacturing technologies remain current with best practice.
- Maintain a strong Governance process for Technology Transfer to enable alignment on progress and risk management.
- Collaborate with stakeholders for effective Analytical Technology Transfer as part of overall program.
- Support process & technology design and associated Commissioning & Qualification activities including process validation.
- Use data from Process Monitoring, Statistical Process Control and Process Capacity Modelling to support robust decision-making and plans for continuous improvement activities.
- Lead the site’s Operational Control Strategy (OCS).
- Develop & lead the process engineering, technical operations components of technology transfers & New Product Introductions.
- Lead the technical input into site PPR (Periodic Product Review) to ensure that the PPR process is a robust assessment of process control.
- Support/Lead significant site technical/batch investigations.
- Interface between Process Development scientists and Operations.
- Interface between R&D and operations.
- Technical point of contact with drug substance manufacturing sites and build relationships with these sites in support of product life cycle activities.
To excel in this role you will need to have:
- Degree and / or Masters or equivalent.
- +10 years in Biopharma industry, +5 years in a leadership role in secondary Biopharma manufacturing.
- Have a proven track record in sterile manufacturing and support operations incl qualification, start-up & early commercialisation.
- Proven track record of building and developing a technical team.
- Ability to seamlessly liaise with internal and external stakeholders.
- Ability to identify gaps / risks and put appropriate remediation plans in place.
- Structure analytical and decision making mind-set.
- A proven track record in enhancing technical capability and developing technical resources to SME level.
- A proven track record in developing process control strategies that support high performing aseptic manufacturing site.
- Strong understanding of aseptic drug product quality and regulatory requirements.
Inspire your Journey
What Sanofi can offer you:
- A role where you are instrumental to creating best practice and as the organisation grows, you can too.
- We offer a generous package including flexible benefits, and are committed to helping you have a healthy work-life balance throughout your career with us.
- Leadership opportunity.
- A newly refurbished gym is available onsite.
- You will be based in our Waterford site which is accessible from M9
- Parking available onsite.
- This is a full time role and we support flexible working.
This is our Sanofi. Discover yours: https://www.sanofi.com/en/careers/
Own your future. Make your move!
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.