Scientist, Analytical Development - Cell Based Assays - Gene Therapy

Scientist, Analytical Development

Location: London

Job summary

This is 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 join the newly created analytical development team at Orchard. The candidate will perform activities related to the development and implementation of analytical methods for the testing, lot release and characterization of OTLs innovative gene-modified cell-based therapeutic products. More specifically, working in the lab, as well as with OTLs designated European Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs), this individual will be responsible for developing and/or optimizing new and existing analytical methods (in-house, in the lab and outsourced) to facilitate the progression of OTLs product pipeline programs.

Key Elements and Responsibilities

• Work in the laboratory to develop and/or re-optimize new and existing analytical methods for the lot release and characterization of HSC-derived gene therapy products with specific cell-based potency assay development expertise.
• Routine operation of potency assays and other analytical methods to support characterisation of HSC-derived gene therapy products as required.
• Oversee analytical method development and optimization with external partners as required.
• Execution, review and approval of method development reports, protocols and process documents as required.
• Assist in the preparation of CMC regulatory submissions.
• Assisting with comparability protocol design and execution as required
• Support CMO production activities as needed
• Other activities as may be assigned

Requirements

Required knowledge

As a proven technical expert in the development, manufacture and delivery of cell-based therapy products with significant applied experience in the biotechnology industry, this candidate will possess:

• Minimum of three years of experience in the biotechnology or pharma industry with a primary focus on the development of analytical methods for product development, characterization and lot release testing.
• Demonstratable experience of development and optimization of cell-based assays (e.g. FACS, HTRF, ELISA, Luminescence, etc) for lot release and characterization.
• Demonstratable experience of engineering cell lines to include (e.g.) vector construction, exogeneous expression of cell surface receptor(s), single cell cloning, etc,
• Demonstratable experience of characterization and maintenance of transfected, clonal and primary cell lines.
• Knowledge of analytical method qualification and validation.
• Experience with the development and application of analytical techniques, including Capillary Electrophoresis, DNA sequencing, qPCR/PCR, ddPCR.
• Experience of the characterization and lot release testing of viral vector-based and/or cell-based products desirable.
• Sound understanding and demonstrated application of statistical methods/tools.

Skills & 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

Education

PhD in Biological Sciences, Bioengineering, Chemistry or an associated discipline
or
Master of Science in related discipline with additional industry experience