Full timeOther

Quality (QA) Lead - CDMO

MytosLondon and Stevenage🇬🇧United Kingdom

Quick overview

SeniorityMid Senior

Employment typeFull Time

Work modeOn Site

LocationLondon and Stevenage, United Kingdom

RoboticsAuditingComplianceContinuous ImprovementFDA Regulations

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 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
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

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.

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