Principal Scientist, Cell and Gene Therapy Technologies

 

Main characteristics

Location

London, London

Company

Orchard Therapeutics

Category

Mental Health

Job summary

Location: UK
Reporting to: Director, Manufacturing Science and Technology
.
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 Senior or Principal Scientist to manage activities related to the development, manufacture and delivery of Orchard Therapeutics innovative gene-modified cell-based therapeutic products. Such activities will include process development, external tech-transfer, and scale-out of HSC-based gene-modified autologous cell products from pre-clinical research through to commercialization. The post-holder will also input into validation and GMP execution of manufacturing processes and controls to support OTL's product pipeline programs.
Key Elements and Responsibilities
Manage the transfer of cell processes and controls between CMOs. Work within a cross-functional and international team to deliver this. Input in strategy, project timelines, required documents and deliverables - including design, execution ad review of PPQ and comparability.
Provide expert compilation, review, editing and approval of batch records, standard operating procedures, investigations, development protocols and reports.
Provide guidance and direction on experiments and reports required and suitable for regulatory submissions.
Participate in regulatory submission authoring.
As required, assist with oversight of manufacturing at company designated Contract Manufacturing Organizations (CMOs) and input in potential process optimisations / improvements.
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 3 years of 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 processes for clinical and/or commercial application: Cell isolation/purification
Cell culture
Cell transduction
Cell washing/volume reduction
Formulation and final fill of cell-based products

In depth expertise of gene therapy vectors and autologous gene modified cellular therapies
Experience with regulatory filings and associated reports/sections writing. In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements
Experience with process characterization and comparability strategies
DOE and QBD experience a plus
The ability to travel domestic and international
Experience in GMP preferred
Experience authoring regulatory documents preferred
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

Skills & Abilities
Education
A minimum PhD or equivalent, in bioprocessing, biological sciences, gene therapy