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Mytos

Automated scalable human cell manufacturing platform

Quality Assurance Lead - Quality Assurance, CDMO

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • Significant quality assurance experience of more than five years in a GxP environment, ideally in advanced therapy medicinal products, biologics, or cell therapy.
  • Strong understanding of Medicines and Healthcare products Regulatory Agency and European Union Good Manufacturing Practice requirements, with hands-on experience preparing for inspections.
  • Experience with pharmaceutical quality systems covering document control, deviations, corrective and preventive actions, change control, validation, and training.
  • Meet Medicines and Healthcare products Regulatory Agency requirements to be a Quality Controller on the Manufacturing and Import Authorisation for Investigational Medicinal Products license.
  • Experience in auditing and being audited.
  • Excellent written and verbal communication skills.

Responsibilities

  • Lead the work to secure an MHRA MIA(IMP) license for the first site as quickly as possible without compromising on quality.
  • Establish and maintain a robust, scalable pharmaceutical quality system.
  • Ensure all aspects of production comply with quality policies and procedures.
  • Improve the team’s understanding of quality and reinforce an efficient quality culture.
  • Work with leadership to plan quality strategy in support of business goals.
  • Lead and support audits.
  • Prepare the organization for future commercial batch release.

Desired Qualifications

  • Experience releasing advanced therapy medicinal products, ideally pluripotent stem-cell-derived cell therapies.
  • Previously establishing a pharmaceutical quality system from scratch and obtaining an MIA(IMP) license.
  • Experience setting up electronic systems such as electronic quality management systems (MasterControl) and electronic batch records/manufacturing execution systems.
  • Knowledge of and experience with Food and Drug Administration regulations.

About the Company

Mytos

Automated scalable human cell manufacturing platform

Mytos.bio provides automated, end-to-end manufacturing for human cell types used in biotech. It sells and supports its proprietary Mytos Platform, which combines robotics and software to run cell culture processes without needing more staff. This turns traditional artisanal cell culture into scalable, repeatable production for large biotech firms working on cell therapies and drug development. The system works by integrating automated equipment and software workflows that manage culture, monitoring, and quality control, enabling consistent, high-quality cells at scale. Compared with competitors, Mytos.bio emphasizes a turnkey, scalable infrastructure that reduces headcount while delivering uniform results, backed by a team of hardware and software engineers and biologists, and recognition as a YCombinator alumnus and Forbes 30 Under 30. Its goal is to make large-scale cell production reliable and cost-effective so biopharma companies can accelerate therapies and drug development.

Company size
11-50
Company stage
Series A
Total funding
$23.2M
Headquarters
London, United Kingdom
Founded
2016

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