Scientist, Analytical Operations (Europe)

 

Main characteristics

Location

London, London

Company

Orchard Therapeutics

Category

Scientific

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 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 European Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs) this individual will manage activities to provide analytical support to facilitate the progression of OTLs product pipeline programs.
Key Elements and Responsibilities
Oversee the analytical functions associated with the development, GMP production and testing of OTLs products
Execution, review and approval of release testing of raw materials, process intermediates, ancillary products, drug substances and drug products
Manage activities at CMOs and CTOs for the development, qualification and implementation of analytical methods, including the design, review and approval of protocols, test records/forms, final reports and Standard Operating Procedures (SOPs)
Oversee QC activities at CMOs and CTOs, including the review and approval of test records/forms, final reports, SOPs and Certificates of Analysis (CoAs)
Oversee the execution of stability programs for raw materials, ancillary products, drug substances and drug products
Drafting and review of SOPs, records/forms and protocols for in-house QC testing and overall analytical operations
Support CMO production activities by coordinating testing activities with appropriate external and in-house departments
Assist in the preparation of CMC regulatory submissions
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 the development, validation and application of analytical methods for product development, characterization and QC testing
Experience of the characterization and QC release testing of viral vector-based and/or cell-based products
Experience with the development, validation and application of analytical techniques in a QC environment, including FACS, High Content Analysis (HCA), ELISA, Capillary Electrophoresis, DNA sequencing, qPCR/PCR, cell culture and cell-based assays
Experience of managing CMO/CTO relationships and projects
Sound understanding and demonstrated application of statistical methods/tools
In-depth knowledge of US and European 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

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 BS in Biological Sciences, Bioengineering, Chemistry or an associated discipline