Scientist, Analytical Sciences

Location
United Kingdom
Posted
Jan 08, 2021
Ref
4CA730BF27
Required Education
Bachelors Degree
Position Type
Full time
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 manage activities related to the development, validation and implementation of analytical methods for the testing, lot release and characterization of OTLs innovative gene-modified cell-based therapeutic products. More specifically, working with OTLs designated Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs) in addition to participation as an integral member of internal teams supporting regulatory agency filings, this individual will manage activities to provide analytical support to facilitate the progression of OTLs product pipeline programs.

Requirements

Key Elements and Responsibilities
  • Preparation and review of analytical sections for OTL CMC regulatory submissions and preparation of responses to regulatory agency questions.
  • Manage activities at CMOs and CTOs for the development, and qualification of analytical methods for OTL programmes including the design, review and approval of associated protocols, test records/forms, final reports and Standard Operating Procedures (SOPs).
  • Manage GMP activities at CMOs and CTOs for the validation and on-going performance of analytical methods for OTL programmes including; review and approval of associated protocols, test records/forms, final reports, and SOPs.
  • Review of SOPs, records/forms and protocols for in-house analytical assay development and qualification and overall analytical operations as required.
  • Active participation on the design and execution of stability programs for raw materials, ancillary products, drug substances and drug products. Review of stability programme data as required.
  • Represent Analytical Sciences on CMC team(s) as required.
  • Execution, review and approval of release testing of raw materials, process intermediates, ancillary products, drug substances and drug products as required.
  • Other activities as may be assigned.

Required Knowledge

As a proven technical expert in the development, manufacture and delivery of cell-based therapy products with 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, validation and application of analytical methods for product development, characterization and GMP testing.
  • Practical experience of preparation of analytical sections for regulatory submissions including preparation of responses to regulatory agency questions on submission documentation.
  • Practical experience and knowledge of the development, qualification, validation and application of analytical techniques in a QC environment including, but not limited to, techniques such FACS, ddPCR, ELISA, Capillary Electrophoresis, DNA sequencing, qPCR/PCR, cell culture and cell-based assays.
  • Practical experience of managing and maintaining CMO/CTO relationships and projects.
  • In-depth knowledge of US and European Pharmacopeia methods and requirements.
  • In-depth knowledge of FDA, EMA, GMP, WHO and ICH regulatory requirements.
  • Sound understanding and demonstrated application of statistical methods/tools would be advantageous.
  • This position requires frequent on-site presence at CMOs and contract vendors. Therefore, ability to travel is a pre-requisite.
  • Experience of working in cross-site, cross-functional matrix teams would be advantageous.

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

Education
  • A minimum B.Sc in Biological Sciences, Bioengineering, Chemistry or an associated discipline