Regulatory Lead - DNA manufacturing

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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. 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

Similar searches: Permanent, Full Time, Cambridge, Engineering