Quality (QA) Lead - CDMO

Job description

About Us You rarely get the chance to change an entire industry. But that's the position we find ourselves in. Join us, and you’ll help scale cures to patients that need them sooner. We’ve developed fully-automated cell manufacturing sites powered by custom robotics - to scale therapies to millions of patients. Last year, patients were cured of diseases like [Parkinson’s](https://www.euronews.com/health/2024/05/08/parkinsons-patient-moves-freely-again-after-world-first-implant-of-lab-grown-cells-into-hi) and vision loss using stem-cell derived cells - but today these Regenerative Medicines are produced by hand, meaning they’re too expensive and hard to scale. With our automated CDMO, these therapies can now be scaled globally at low cost. We've announced partnerships across multiple therapies so far ranging from [Parkinson’s](https://www.genengnews.com/topics/bioprocessing/aspen-partners-with-mytos-to-automate-stem-cell-production-for-parkinsons-therapy/), [to hearing loss, to bone repair](https://endpoints.news/exclusive-mytos-inks-cell-therapy-manufacturing-deals-with-three-european-biotechs/) - and raised $24m to expand into the market faster, and accelerate our development! Within the next 12-18 months, neurons grown on our machines will be going into Parkinson’s patient brains. We’ve assembled a world-class team to take on this challenge, with ex-Dyson engineers and Nature-published scientists working hand-in-hand. You can learn more about your potential Mytos teammates here: [Team](https://www.mytos.bio/team) Mytos is backed by Y Combinator, the most successful startup program in the world which produced companies such as AirBnb, Dropbox, and Ginkgo Bioworks. The Role We’re looking for an ambitious and pragmatic Quality Assurance Lead to work with leadership to ensure quality moves in hand in hand with business vision. You’ll work on moving us fast towards our MHRA Manufacturing and Import Authorisation (MIA) license for our first site. You’ll get to collaborate with our advisors, such as former VP Quality for Cell and Gene Therapy at Catalent, and the former CTO of Regenerative Medicine at Resilience. This is a unique opportunity to establish quality at the world’s first automated CDMO for Regenerative Medicine. ### What you'll be doing: - Lead Mytos an MHRA MIA(IMP) license for our the 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 - Have previously setup 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 very high potential to learn new skills - 24 days holiday (excluding bank holidays) - Pension