Scientist/Senior Scientist, Analytical Sciences

Location
London, United Kingdom
Posted
Jul 05, 2021
Ref
D6C45365B9
Required Education
Bachelors Degree
Position Type
Full time
Scientist/Senior Scientist, Analytical Sciences

Location: London, UK

Reporting to: Director, 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 manage and perform 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.

Key Elements and Responsibilities
  • 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 perform of analytical methods for OTL programmes including review and approval of associated protocols, test records/forms, final reports and SOPs.
  • Laboratory-based 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) as required.
  • Preparation and review of analytical sections for OTL CMC regulatory submissions including review of CMC regulatory submissions as part of the wider OTL CMC team(s) and preparation and review of responses to regulatory agency questions.
  • Execution, review and approval of release testing of raw materials, process intermediates, ancillary products, drug substances and drug products 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.
  • Review of SOPs, records/forms and protocols for in-house analytical assay development and qualification and overall analytical operations as required.
  • 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 five years of experience in the biotechnology or pharma industry with a primary focus on hands-on development, validation and application of analytical methods for product development, characterization and GMP testing.
  • 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 European and US Pharmacopeia methods and requirements.
  • In-depth knowledge of FDA, EMA, GMP, WHO and ICH regulatory requirements.
  • This position requires frequent on-site presence at CMOs and contract vendors. Therefore, ability to travel is a pre-requisite.
  • Practical experience of preparation of analytical sections for regulatory submissions including preparation of responses to regulatory agency questions on submission documentation would be advantageous.
  • Sound understanding and demonstrated application of statistical methods/tools would be advantageous.
  • Experience of working in cross-site, cross-functional matrix teams would be advantageous.

Skills and Abilities
  • Excellent written and oral communication skills
  • Excellent interpersonal skills
  • Outstanding organizational skills
  • A minimum Ph.D or equivalent experience in Biological Sciences, Bioengineering, Chemistry or an associated discipline

Creative problem solver

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

Education

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.

We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.

Notice to All Applicants: Orchard Therapeutics participates in E-Verify