Reporting to: Senior Manager, Analytical Sciences, MSAT
Location: London
Job Summary
We are seeking an enthusiastic Senior Scientist to join our Analytical Science & Technology (AST) group in the Manufacturing Science and Technology (MSAT) organization, specifically within the cell gene therapy sector. The successful candidate will support the verification/validation and deployment of release and stability methods for Orchard products, as well as monitoring of methods and trends. This role includes responsibilities for deviation management and change control support. Experience with in-vitro potency and safety/microbiology methods would be a plus.
Key Responsibilities
* Assist the Analytical Sciences team within the MSAT organization to verify, validate, deploy, and manage analytical methods to ensure product quality and compliance with applicable guidelines and regulatory requirements.
* Support Analytical activities at CMOs and CTOs, including defining appropriate system suitability criteria and controls for assays, performing periodic assay and data reviews, and assisting with the preparation of analytical final reports and SOPs.
* Aid in troubleshooting and investigations into out-of-specification/trend results for drug substances, drug products, and stability programs for raw materials, ancillary products, and plasmids.
* Support stability studies to ensure the consistent quality and safety of products and starting material (such as plasmids).
* Assist in preparing and authoring quality reports and documentation related to the development, characterization, and testing of analytical methods, as well as relevant sections of CMC documentation in support of regulatory submissions and dossier amendments.
Required Knowledge
* Knowledge in Cell and Gene Therapy analytics, particularly in areas such as lentiviral vectors, plasmids, and cell banks. Experience with microbiology and other safety analytical techniques, and cell-based potency assays.
* Experience with management of quality records
* Understanding of the verification, validation, and trending of assay performance is desirable
* Basic understanding of regulatory authority inspections, including both FDA and EMA inspections is desirable.
* Excellent Knowledge of GMP.
Skills & Abilities
* Strong scientific and technical proficiency with an awareness of developments in novel testing technologies within the industry.
* Excellent attention to detail, communication, presentation, and organizational skills.
* Effective troubleshooting abilities and the capacity to work independently and as part of a team.
* Creative problem solver with the ability to operate in a fast-paced, multi-disciplinary industrial environment.
Education and Experience
* Minimum of a BSc in a relevant scientific discipline, such as Chemistry, Biochemistry, Molecular Biology, Cell Biology, Chemical Engineering, or another relevant field.
* Some experience in the biotechnology or pharma industry with a focus on the verification, validation, and application of analytical methods for product development, stability and commercial release testing is preferred.
#J-18808-Ljbffr