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For Companies At a Glance
- Tasks: Lead quality assurance efforts to ensure compliance and support rapid growth in regenerative medicine.
- Company: Innovative biotech startup transforming the industry with automated cell manufacturing.
- Benefits: Competitive salary, stock options, daily lunch, 24 days holiday, and a collaborative team culture.
- Why this job: Join a mission-driven 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.
- Other info: Fast-paced environment with opportunities for continuous learning and career growth.
The predicted salary is between 36000 - 60000 ÂŁ per year.
About Us
You rarely get the chance to change an entire industry. But thatâs the position we find ourselves in. Join us, and youâll help scale cures to patients that need them sooner.
Weâve 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 Parkinsonâs and vision loss using stem-cell derived cells - but today these Regenerative Medicines are produced by hand, meaning theyâre too expensive and hard to scale. With our automated CDMO, these therapies can now be scaled globally at low cost.
Weâve announced partnerships across multiple therapies so far ranging from Parkinsonâs, 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 Parkinsonâs patient brains.
Weâve assembled a worldâclass team to take on this challenge, with exâDyson engineers and Natureâpublished scientists working handâinâhand. 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
Weâre looking for an ambitious and pragmatic Quality Assurance Lead to work with leadership to ensure quality moves in hand in hand with business vision. Youâll work on moving us fast towards our MHRA Manufacturing and Import Authorisation (MIA) license for our first site. Youâll 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 worldâs first automated CDMO for Regenerative Medicine.
What youâll be doing:
- Lead Mytos to 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 teamâs 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 handsâon 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 PSCâderived Cell Therapies
- Have 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 very high potential to learn new skills
- 24 days holiday (excluding bank holidays)
- Pension
Weâre 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 fastâpaced environment, where youâre empowered to make decisions and do the best work of your career.
Quality (QA) Lead - CDMO in London employer: Mytos & Aspen
Contact Detail:
Mytos & Aspen Recruiting Team
StudySmarter Expert Advice đ€«
We think this is how you could land Quality (QA) Lead - CDMO in London
âšTip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at companies you're interested in. A friendly chat can open doors and give you insider info that could help you stand out.
âšTip Number 2
Prepare for interviews by researching the company and its culture. Understand their mission and values, and think about how your experience aligns with their goals. This will show them you're genuinely interested and a great fit!
âšTip Number 3
Practice your pitch! Be ready to explain why you're the perfect candidate for the Quality Assurance Lead role. Highlight your relevant experience and how you can contribute to their mission of scaling therapies efficiently.
âšTip Number 4
Don't forget to apply through our website! Itâs the best way to ensure your application gets noticed. Plus, it shows you're serious about joining our team and making a difference in the industry.
We think you need these skills to ace Quality (QA) Lead - CDMO in London
Some tips for your application đ«Ą
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 and how excited you are about making a difference in the industry.
Tailor Your CV: Make sure to customise your CV to highlight relevant experience that matches the job description. We love seeing how your background fits into our vision, so donât hold back on showcasing your QA expertise!
Be Clear and Concise: Keep your application straightforward and to the point. We appreciate clarity, so avoid jargon and make it easy for us to understand your qualifications and experiences. Remember, less is often more!
Apply Through Our Website: We encourage you to submit your application directly through our website. Itâs the best way for us to receive your details and ensures youâre considered for the role. Plus, itâs super easy!
How to prepare for a job interview at Mytos & Aspen
âšKnow Your Quality Standards
Make sure you brush up on your knowledge of MHRA and EU GMP regulations. Be ready to discuss how your experience aligns with these standards, especially in relation to ATMPs and biologics. This will show that you understand the critical quality aspects needed for the role.
âšShowcase Your Leadership Skills
Prepare examples of how you've led teams in establishing quality assurance processes. Highlight any experiences where youâve successfully implemented a PQS or prepared for audits. This will demonstrate your capability to elevate the team's quality understanding and reinforce an efficient quality culture.
âšBe Ready for Fast-Paced Questions
Since the company thrives in a fast-paced environment, expect questions that assess your adaptability and decision-making skills. Think of scenarios where you had to make quick decisions without compromising quality, and be ready to share those stories.
âšEngage with Their Vision
Familiarise yourself with the company's mission to scale regenerative medicines. Be prepared to discuss how your role as a QA Lead can contribute to this vision. Showing genuine interest in their goals will set you apart as a candidate who is not just looking for a job, but is passionate about making a difference.
