Orchard Therapeutics

Scientist - Analytical Sciences

BiotechMid
Orchard Therapeutics
's Mission

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.

Requirements

  • 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

Company Values

Company Benefits

  • Work from home opportunities
  • Health insurance
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