Scientist/Senior Scientist Plasmid/Vector Analytics, Analytical Sciences

Location: London, UK

Reporting to: Director, Analytical Sciences

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 suitable candidate to manage analytical activities related to the production of OTL plasmids including plasmid cell banking. The candidate will also support /lead outsourcing of the development of vector analytical methods suitable for in-process testing, batch release and characterization of OTLs innovative gene-modified cell-based therapeutic products. This individual will manage activities to provide analytical support to facilitate the progression of OTLs product pipeline programs working with OTLs designated Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs) as well as internal teams supporting regulatory agency filings.

Key Elements and Responsibilities

• Provide technical oversight and manage analytical activities at CMO and CTOs related to Cell banking and subsequent production of plasmids for OTL programmes. This includes, but is not limited to, the design, review and approval of associated manufacturing documentation and specifications, protocols, test records/forms, final reports and QMS records (Change controls, Deviations etc.) in compliance with the relevant quality standards.
• Provide technical oversight and manage activities at CDMOs and CTOs for the development, qualification and validation of analytical lot release and characterization methods for OTL programmes with a specific focus on viral vector analytics. Activities to include review and approval of associated protocols, test records/forms and final reports.
• Preparation and review of analytical documentation required for OTL CMC regulatory submissions including review of CMC regulatory submissions as part of the wider OTL CMC team(s) and preparation and review of responses to regulatory agency questions.
• Participation in design and execution of internal vector analytical assays including design, review and approval of associated protocols, test records/forms, final reports and Standard Operating Procedures (SOPs) may be required.
• Represent Analytical Sciences on CMC team(s) as required.
• Other activities as may be assigned

Requirements

Required Knowledge

As a proven technical expert in the development and manufacture of nucleic acid production by bacterial fermentation for use in gene and cell therapy with significant applied experience in the biotechnology industry, this candidate will possess:

• Minimum of three years of experience in the biotechnology or pharma industry with a primary focus on hands-on development of plasmid and viral vector product development, manufacture, characterization and testing to GMP standards.
• Practical experience and knowledge of the development, qualification, validation and application of analytical techniques in a QC environment including, but not limited to, techniques such ddPCR, ELISA, Electrophoresis, HPLC, DNA sequencing, qPCR/PCR, cell culture and cell-based assays.
• Demonstratable knowledge of US and European Pharmacopeia methods and requirements and ICH guidelines.
• Practical experience of managing and maintaining CMO/CTO relationships and projects would be advantageous.
• Experience of preparation of analytical sections for regulatory submissions including preparation of responses to regulatory agency questions on submission documentation would be advantageous.
• This position requires frequent on-site presence at CMOs and contract vendors. Therefore, ability to travel is a pre-requisite.
• Experience of working in cross-site, cross-functional matrix teams, and with analytical method transfer would be advantageous.

Skills and Abilities

• Excellent written and oral communication skills
• Attention to detail
• Excellent interpersonal skills
• Outstanding organizational skills
• A minimum Ph.D or equivalent experience in Biological Sciences, Bioengineering, Pharmacology, Molecular Biology or an associated discipline.

Creative problem solver

Ability to operate in a fast-paced, multi-disciplinary industrial environment

Education

Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.

We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.