At a Glance
- Tasks: Lead quality assurance efforts for groundbreaking automated cell manufacturing.
- Company: Innovative biotech company transforming regenerative medicine with cutting-edge technology.
- Benefits: Competitive salary, stock options, daily lunch, and 24 days holiday.
- Other info: Fast-paced environment with opportunities for continuous learning and career growth.
- Why this job: Join a passionate team making real-world impacts in healthcare and patient lives.
- Qualifications: 5+ years QA experience in GxP environments, strong knowledge of MHRA and EU GMP.
The predicted salary is between 48000 - 84000 £ per year.
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.
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.
Quality (QA) Lead - CDMO employer: Mytos
At Mytos, we are revolutionising the Regenerative Medicine industry with our cutting-edge automated CDMO, offering a unique opportunity for the Quality Assurance Lead to shape quality standards in a fast-paced, innovative environment. Our collaborative culture fosters continuous learning and growth, supported by competitive salaries, stock options, and comprehensive benefits, including daily lunch and 24 days of holiday. Join us to be part of a world-class team dedicated to scaling life-changing therapies for patients globally.
StudySmarter Expert Advice🤫
We think this is how you could land Quality (QA) Lead - CDMO
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at Mytos or similar companies. A friendly chat can open doors and give you insights that might just land you an interview.
✨Tip Number 2
Prepare for your interviews by researching the company and its mission. Understand their products and how they’re changing the game in regenerative medicine. This will show your genuine interest and help you stand out.
✨Tip Number 3
Practice common interview questions, but also be ready for technical ones related to QA and GxP environments. We want to see how you think on your feet, so don’t shy away from showcasing your expertise!
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining our team and contributing to something truly impactful.
We think you need these skills to ace Quality (QA) Lead - CDMO
Some tips for your application 🫡
Show Your Passion:When writing your application, let your enthusiasm for the role and our mission shine through. We want to see how your values align with ours, especially in transforming the industry and making therapies accessible to patients.
Tailor Your CV:Make sure your CV is tailored to highlight your relevant QA experience, especially in GxP environments. We’re looking for specific examples that demonstrate your understanding of MHRA and EU GMP, so don’t hold back!
Craft a Compelling Cover Letter:Your cover letter is your chance to tell us why you’re the perfect fit for the Quality Assurance Lead role. Share your journey, your achievements, and how you plan to contribute to our ambitious goals at Mytos.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity to join our team!
How to prepare for a job interview at Mytos
✨Know Your Quality Standards
Make sure you brush up on your knowledge of MHRA and EU GMP regulations. Being able to discuss these standards confidently will show that you're not just familiar with the rules, but that you can apply them in a practical setting.
✨Showcase Your Experience
Prepare specific examples from your past QA roles, especially those involving ATMPs or biologics. Highlight how you've successfully navigated audits or set up PQS systems, as this will demonstrate your hands-on experience and problem-solving skills.
✨Emphasise Team Collaboration
Since this role involves working closely with leadership and advisors, be ready to discuss how you've collaborated with cross-functional teams in the past. Share instances where your input helped shape quality strategies or improved team understanding of quality culture.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's vision for quality assurance and how it aligns with their rapid growth. This shows your genuine interest in the role and helps you gauge if the company’s values match yours.
