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Walker Cole International is supporting an innovative biotech company looking for a Director of Process Development to join their team. As Director of Process Development, you will lead efforts to develop and optimise manufacturing processes for cutting-edge biologics, ensuring readiness for clinical trials and smooth transfer to external manufacturing partners.
What you'll be doing as Director Process Development:
- Leading process development initiatives, from early-stage experiments to preparing scalable manufacturing protocols for external production.
- Overseeing technology transfers and working closely with Contract Development and Manufacturing Organisations (CDMOs) to ensure high-quality and seamless production runs.
- Collaborating with internal teams across R&D, manufacturing science, and quality to align development objectives with company milestones.
- Supporting regulatory submissions by ensuring processes meet global standards, including cGMP requirements.
- Driving innovation in biologics process development to support ambitious company growth and improve efficiency across external manufacturing partnerships.
What we're looking for in a Director of Process Development:
- Advanced degree (PhD or MSc) in biochemistry, chemical engineering, biotechnology, or a related field.
- Proven industry experience in biologics process development and/or manufacturing.
- Deep knowledge of mammalian cell culture, protein purification, process validation, and related automation technologies.
- Expertise in regulatory guidelines, including cGMP, FDA, EMA, and ICH, with a strong track record in successful regulatory submissions.
- Demonstrated leadership and a collaborative mindset, thriving in fast-paced, dynamic environments.
Process Development | Director Process Development | Biologics | Process Optimisation | Technology transfer | Protein purification| Regulatory compliance | cGMP | ICH | FDA | EMA | Manufacturing | CDMO
