Dedicated to transforming the lives of patients with inherited diseases through innovative gene therapy.
What you'll be doing
- Being responsible for the development and qualification of analytical methods for OTL programmes including the design and review of associated protocols, test records/forms, final reports and Standard Operating Procedures (SOPs).
- Specific responsibility for development of methods such as ddPCR, ELISA, Capillary Electrophoresis, DNA sequencing, qPCR/PCR and vector analysis. Other methods as required.
- Preparing and reviewing SOPs, records/forms and protocols for both internal and external analytical assay development and qualification and overall analytical operations as required.
- Supporting analytical activities at CMOs and CTOs for the development, qualification and validation and on-going performance of analytical methods of OTL programmes including review and approval of associated protocols, test records/forms, final reports and SOPs as required.
- Representing Analytical Sciences on CMC team(s) as required.
- Preparing analytical sections for OTL CMC regulatory submissions including review of CMC regulatory submissions as part of the wider OTL CMC team(s) as required.
- Minimum of three years experience in the biotechnology or pharma industry with a primary focus on the development and qualification of multiple analytical methods for product development, characterization and GMP testing of biologics. Experience in characterization and QC release testing of viral vector-based and/or cell-based products preferred.
- Practical experience and knowledge of the development and qualification of ddPCR, ELISA, Capillary Electrophoresis, DNA sequencing, qPCR/PCR methods. Practical experience of flow cytometry and cell culture of clonal and primary cell lines would be desirable.
- Practical experience of transfer of analytical methods to GMP laboratories.
- Specific knowledge of US and European Pharmacopeia methods and requirements for analytical methods.
- Maintain accurate and up-to-date records of all proposals and experiments according to OTL policies.
- Sound understanding and demonstrated application of statistical methods/tools would be advantageous.
- Excellent interpersonal skills
- Outstanding organizational skills
- A minimum M.Sc or equivalent experience in Biological Sciences, Bioengineering, Chemistry or an associated discipline
- Work from home opportunities
- Health insurance
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