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, Cell Therapy Operations (Europe) - Innovative Gene Therapy Start Up

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

Job Summary:

Orchard Therapeutics, Ltd. (OTL) is looking for a Director, Cell Therapy Operations to manage activities related to the development, manufacture and delivery of Orchard Therapeutics innovative gene-modified cell-based therapeutic products.

Requirements:

Location: London, UK

Reporting to: Senior Vice President, Cell Therapy 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, Cell Therapy Operations to manage activities related to the development, manufacture and delivery of Orchard Therapeutics innovative gene-modified cell-based therapeutic products. Such activities will include the validation and execution of manufacturing processes at European Contract Manufacturing Organizations (CMOs) supporting OTL’s product programs in clinical trials and subsequent commercialization.

Responsibilities

Manage the implementation and validation of cell isolation, cell culture and cell transduction processes and controls at company designated European CMOs

Manage the GMP production and distribution of gene-modified cell-based products to support clinical trials and commercial supply

Lead 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 gene-modified cell therapy products

Co-ordinate production activities with the QA, QC, clinical development and commercial departments to ensure the successful achievement of company timelines and milestones

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, manufacture, distribution and delivery of cell and gene-based therapy products

In-depth technical experience with a proven track record of developing, integrating and implementing equipment and platforms for closed system:

Cell isolation/purification

Cell culture

Cell transduction

Cell washing/volume reduction

Formulation and final fill of cell-based products

Proven experience of the set-up, technology transfer and validation of manufacturing processes at CMOs

In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements

DOE, PAT and QBD experience a plus

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 or equivalent, in bioprocessing, medical technology, chemical engineering, or biological sciences

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

Fluency in French, German or Italian a plus

 

Apply for this job: Director, Cell Therapy 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

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.