4basebio is an innovative gene synthesis company with the ambition to provide high quality, synthetic DNA for use in gene therapies and gene vaccines. The company is setting up a manufacturing cell with associated quality system to produce synthetic DNA and related therapeutic products at our site near Cambridge, UK.
We are now looking for a Regulatory Lead to join our team.
Responsibilities:
• Coordinate the delivery of regulatory support files for the company’s novel DNA products
• Design and implement a quality process to complement the technical manufacturing process being developed on site
• To undertake any other appropriate roles and responsibilities that reasonably fall within the role holder’s skills and experience as requested
• Be prepared to travel to other 4basebio sites
Person Specification:
• Experience of working under GMP regulation, ideally within advanced therapeutics
• Experience of developing quality systems in a manufacturing environment
• PhD or 5 years’ experience in Biological Sciences, Synthetic Biology, or Bio Chem engineering manufacturing
• Delivery of regulatory support packages for life sciences
• Ability to work in a self-directed way in a small team
What we can offer:
Competitive salary + private healthcare + pension contributions + life assurance
Please note we are unable to consider candidates who do not hold the right to work in the UK
NO AGENCIES PLEASE
To apply, send your CV and covering email to HR@4basebio.com