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Job Details

Director, Analytical Operations (Europe) - Innovative Gene Therapy Start Up

Company: Orchard Therapeutics
Location: London
Reference: JP/DAO/1
Closing Date: 12 Mar 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Orchard Therapeutics, Ltd. (OTL) is looking for a Director, Analytical Operations 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.

Requirements:

Location: London, UK

Reporting to: Vice President, Analytical Operations

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 Director, Analytical Operations 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) this individual will manage activities to provide analytical support to facilitate the progression of OTLs product pipeline programs.

Responsibilities

Manage 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)

Manage QC activities at CMOs and CTOs, including the review and approval of test records/forms, final reports, SOPs and Certificates of Analysis (CoAs)

Establish and oversee/execute 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

Job Requirements

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:

Extensive 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 a plus

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

Education & skills

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

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

 

Apply for this job: Director, Analytical Operations (Europe) - Innovative Gene Therapy Start Up

Contact Information:

Address:  Head Office
Birchin Court, 20 Birchin Lane, London
EC3V 9DU
England
Tel:  (0) 203 384 6700
Website:  Visit Our Web Site

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