Senior Associate, Analytical Sciences

Location
London, United Kingdom
Posted
Jul 17, 2021
Ref
D6627CB7EA
Required Education
Masters Degree/MBA
Position Type
Full time
Location: London, UK

Reporting to: Senior Scientist, Analytical Sciences

Job Summary

This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.

Orchard Therapeutics, Ltd. (OTL) is looking for a suitable candidate to perform activities related to the development and qualification of analytical methods for the testing, lot release and characterization of OTLs innovative gene-modified cell-based therapeutic products. More specifically, the successful candidate will be responsible for the development and qualification of cell and vector analytical release and characterisation assay methods. The candidate will also support assay transfer of methods to OTLs designated Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs) as required.

Key Elements and Responsibilities
  • Lab-based role with responsibility for the development and qualification of analytical methods for OTL programmes.
  • Responsible for activities including the design and drafting of protocols, test records/forms, final reports and Standard Operating Procedures (SOPs) to support internal analytical assay development and qualification as required.
  • Responsible for development of methods including FACS, ddPCR, ELISA, Capillary Electrophoresis, DNA sequencing, qPCR/PCR, vector analysis and other methods as required.
  • Support transfer of internally developed methods to OTL's designated CMOs and CTOs.
  • Responsible for maintaining accurate and up-to-date records of all experiments according to OTL policies.
  • Present method development plans and results to the wider department and functional teams as requested. Representation of Analytical Sciences on CMC team(s) may be required.
  • Support development and qualification of analytical methods at CMOs and CTOs as required. This may include reviewing protocols, final reports, SOPs and on-going analytical method performance as required,
  • Contribute to preparation of analytical sections for OTL CMC regulatory submissions as required.
  • Other activities as may be assigned.


Requirements

Required Knowledge

The successful candidate will possess a Batchelor of Science or Master of Science with 2 or more years of relevant experience. Industrial experience is preferred.
  • Demonstratable experience of the development of techniques such as flow cytometry, ddPCR, ELISA, Capillary Electrophoresis, DNA sequencing, qPCR/PCR and cell culture (clonal and primary cells lines).
  • Knowledge of FDA, EMA, GMP, WHO and ICH regulatory requirements for analytical methods would be an advantage.
  • Experience of transfer of analytical methods to GMP laboratories would be desirable.

Skills and Abilities
  • Excellent interpersonal skills
  • Outstanding organizational skills
  • Excellent written and oral communication skills

Creative problem solver

Ability to operate in a fast-paced, multi-disciplinary industrial environment

Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.