About Us
We develop fully‑automated cell manufacturing sites powered by custom robotics to scale therapies to millions of patients. Our automated CDMO enables regenerative medicines to be produced globally at low cost. The team includes former Dyson engineers and Nature‑published scientists.
The Role
We’re looking for an ambitious and pragmatic Quality Assurance Lead to work with leadership to ensure quality moves hand‑in‑hand with business vision. You’ll help secure the MHRA Manufacturing and Import Authorisation (MIA) license for our first site and establish quality at the world’s first automated CDMO for regenerative medicine.
What you’ll be doing
- Lead Mytos to obtain the MHRA MIA(IMP) license for our first site as fast as possible, without compromising on quality.
- Take the lead in establishing a robust and scalable PQS, and maintaining it.
- Ensure all aspects of our production are managed in compliance with our quality policies and procedures.
- Elevate the team’s quality understanding, and reinforce an efficient quality culture.
- Work with leadership to plan quality strategy to hit our business goals.
- Lead and support audits.
- Prepare Mytos for future commercial batch release.
You bring
- Significant QA experience (>5 years) in a GxP environment, ideally in ATMPs, biologics, or cell therapy.
- Strong understanding of MHRA and EU GMP, with hands‑on experience preparing for inspections.
- Experience with PQS systems covering document control, deviations, CAPA, change control, validation, and training.
- You meet MHRA requirements to be a Quality Controller on the MIA(IMP) license.
- Experience in auditing and being audited.
- Comfortable working in a fast‑paced environment.
- Excellent written and verbal communication skills.
Nice to have
- Experience in the release of ATMP products – ideally PSC‑derived cell therapies.
- Previously set up a PQS from scratch and obtained a MIA(IMP) license.
- Experience setting up electronic systems such as eQMS (MasterControl) and electronic batch records/manufacturing execution systems.
- Knowledge and experience with FDA regulations.
Salary and Benefits
- Competitive salary with stock options.
- Lunch covered daily.
- Collaborative team environment with high potential to learn new skills.
- 24 days holiday (excluding bank holidays).
- Pension.
We’re building a team that enjoys moving fast, strives for continuous improvement through learning from mistakes, and is passionate about work that contributes to solving real world problems. Join us if you want a fast‑paced environment where you’re empowered to make decisions and do the best work of your career.
