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Associate Director, Vector Operations
 
Title: Associate Director, Vector Operations
Category: Other
Job type: Permanent
Job status: Full Time
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Description:
Location: London, UK

Reporting to: Senior Director, Vector 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 an individual to join a London-based team responsible for activities related to the development and cGMP production of lentiviral vectors at European contract manufacturing organizations (CMOs). Such activities will include the scale-up, validation and execution of manufacturing processes and controls to support Orchard Therapeutics innovative cell and gene therapy product programs from Phase I clinical trials through to commercial.

Requirements

Responsibilities

Manage the GMP production, testing and fill finish of lentiviral vectors at CMO's Drive activities for the DoE, protocol generation, execution and reporting of studies to validate production processes and associated assay method controls to support BLA/MAA submissions for company products As required, provide on-site person-in-plant oversight during production campaigns and key development/validation activities Assist in the reporting, investigation and resolution of deviations encountered during GMP production activities Provide expert compilation, review, editing and approval of master production records, standard operating procedures, development/validation protocols and reports Provide expert review and approval of executed batch, records, test records and associated documentation for release of lentiviral vector lots and for plasmid lots used in their production Other activities as may be assigned Job Requirements

The ideal candidate for this position will have demonstrated experience of the large-scale cGMP production of lentiviral vectors, including upstream cell culture, downstream processing, and fill finish operations.

Candidate must possess:

Extensive experience in the biotechnology or pharma industry with a primary focus on upstream cell culture, downstream processing, and fill finish operations for biologics In depth knowledge of lentiviral vector construction and biology In-depth experience of the large-scale cGMP production of lentiviral vectors, including Upstream cell culture, downstream processing, and fill finish operations Process characterization and validation Proven track record of managing lentiviral vector development, validation and production both in-house, and at CMO’s/partners Demonstrated ability to build and lead technical teams in fast-paced operational environments In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements for biologics Knowledge of Quality Systems, QBD and PAT as they relate to GMP production operations, process optimization and process validation This position requires on site person-in-plant presence at CMOs and contract vendors. Therefore, ability to travel is a pre-requisite Education & skills

Minimum BSc or equivalent in bioprocessing, chemical engineering, vector biology, or biological sciences Experience of managing CMO relationships and projects Working knowledge of US and European regulatory requirements Ability to operate in a fast-paced, multi-disciplinary industrial environment Fluency in French, German or Italian a plus Excellent interpersonal skills Outstanding organizational skills Excellent written and oral communication skills
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