Senior Scientist, Analytical Sciences, MSAT

Orchard Therapeutics

Orchard Therapeutics

London, UK
Posted on Friday, January 19, 2024

Location: London

Job Summary

The successful candidate will be responsible for supporting thelate-phaseAnalytical Sciences team and the qualification/validation and deployment of all analytical methods and the implementation of effective control strategies and assessment of CQAs in support of product lifecycle management.

The individual will have relevant experience in Cell Gene Therapy products particularly in viral vector and cell therapies. Experience of microbiology and other analytical techniques in a QC environment, such as FACS, High Content Analysis (HCA), ELISA, Capillary Electrophoresis, DNA sequencing, qPCR/PCR, cell culture and cell-based assays, is desired.

The post-holder will have a comprehensive understanding of GMP, statistical methods and quality control of data, with excellent attention to detail, communication, presentation, and organizational skills, effective troubleshooting ability, and the ability to work independently and as part of a team.

Key Responsibilities

· Support the Analytical Sciences team within the MSAT organization to qualify, validate, deploy and manage analytical methods to ensure product quality and compliance with applicable ICH guidelines and FDA/EMA and other global health authority requirements and expectations; and provide technical input into selecting the most appropriate methodology, assay development and design.

· Oversee QC activities at CMOs and CTOs, including defining appropriate system suitability criteria and controls for assays, performing the periodic assay and data reviews; and approval of analytical final reports, SOPs

· Oversee troubleshooting and investigations into out of specification/trends results for drug substances, drug products and stability programs for raw materials, ancillary products

· Support drug product characterization analysis and establishment of cellular gene therapy product CQA and markers that predict clinical efficacy and safety.

· Engage in collaborations with internal and external stakeholders and industry trade organizations to identify trends and expectations and incorporate them into Orchard’s analytical control strategies.

· Provide input into science-based, phase appropriate, and risk-based analytical validation strategy and specification setting to support clinical programs from pivotal phase to commercial registration and managed analytical assays for commercial products.

· Support the authoring and reviews of quality reports and documentation related to development, characterization and testing of analytical methods, as well as relevant sections of CMC documentation in support of regulatory submissions, dossier amendments as well as interactions with regulatory authorities.

· Serve as subject matter expert for analytical methods relevant to testing of Orchard products