Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Director, Vector Operations - Innovative Gene Therapy Start Up

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

Job Summary:

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:

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.

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

Apply for this job: Director, Vector Operations - 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

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.