Walker Cole International is exclusively supporting an innovative and fast-growing biotech in Dublin who is looking to expand their CMC expertise and bring in an experienced CMC Lead.
This role sits within a growing Biologics team, with a dedicated CMC Lead assigned to each programme. You'll act as the technical lead for your programmes, coordinating cross-functional teams across upstream, downstream and analytical development whilst serving as the main point of contact for clients and internal stakeholders.
What you'll be doing:
- Leading end-to-end CMC programmes across biologics and ATMPs.
- Defining and communicating technical strategy across multidisciplinary project teams.
- Acting as the key client-facing technical lead throughout programme delivery.
- Coordinating upstream, downstream and analytical activities to support programme objectives.
- Driving decision-making, risk management and programme progression.
- Identifying opportunities to expand programmes and deliver additional value through a CMC lens.
- Building strong relationships internally and externally to ensure successful outcomes.
What we're looking for:
- Extensive industry experience within biologics development.
- Experience leading cross-functional CMC programmes and project teams.
- A strong understanding of early-stage development, including Phase I and first-in-human programmes.
- Experience across modalities such as vaccines, antibodies, recombinant proteins and viral vectors.
- Strong stakeholder management and communication skills, with the ability to balance technical depth and commercial awareness.
- A proactive mindset, high degree of ownership and the adaptability required to thrive in a fast-paced environment.
CMC | Biologics | ATMP | Vaccines | Antibodies | Recombinant Proteins | Viral Vector | Phase I | First-in-Human | Technical Lead | Cross-Functional | Dublin