Quality (QA) Lead - CDMO
UK Visa Sponsorship Analytics
Analytics are greyed out due to low classification confidence (29.0%).
Occupation Type
IT quality and testing professionals
Occupation Code Skill LevelHigher Skilled
Sponsorship Salary Threshold
£41,700
(£21.38 per hour)
Standard minimum applies
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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 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, to hearing loss, to bone repair - 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
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:
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 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, to hearing loss, to bone repair - 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
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
- 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
- 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
- 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
Join us if you want a fast-paced environment, where you’re empowered to make decisions and do the best work of your career.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your d
ata is processed, please contact us.