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Senior Scientist / Scientist, Cell Process MSAT
Location: London, UK
Reporting to: Head of DP MSAT, Cell and Gene Therapy Technologies
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 Scientist / Scientist to join the Cell and Gene Therapy Technology Department to support GMP manufacture and commercialization of gene therapy products at CDMOs. This role requires good knowledge of HSC-based gene-modified autologous cell products, experience with GMP manufacture (vector manufacture, cell and gene therapy or biopharmaceutical manufacture), an interest in process validation and skills in experimental design and data analysis. You will work with cross functional teams and with CDMOs to generate appropriate documentation to monitor batch process performance and ensure control of manufacturing process across OTL's product pipeline programs.
The position is opened for a Senior Scientist or Scientist, depending on experience.
Key Elements and Responsibilities
Support clinical and commercial GMP production and testing of drug substance / drug product at CDMOs
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 drug product lots
Collect, assemble, analyse and summarise Production data
Ensure continuous trending and verification of drug products manufacturing data and timely analyses and report of trends
Assist with the reporting, investigation and resolution of deviations encountered during GMP production activities in collaboration with other departments
Support activities related to process characterization and validation/qualification including data analysis using appropriate statistical methods
Support development or optimization of processes at CDMO
Work with QA, QC, Reg, CMC project management and other departments to advance programs
Support implementation of process changes
Author/ review of technical documents related to Health Authority submissions, PPQ deliverables, deviations and process monitoring
Collaborate with Process development team to transfer cell processes from development laboratories to CDMO and between CDMOs
Potential to provide on-site person-in-plant oversight during production campaigns and key development/validation activities
Provide expert support for data collation, authoring and data integrity of regulatory documentation

Requirements
Required knowledge
Understanding of the Product Life Cycle, with reference to industry standards and guidelines
Experience with risk-based approaches, such as Failure Modes and Effects Analysis
Experience with GMP manufacturing or process development within the pharmaceutical or biopharma industry, in cell-based processes, cell and gene therapy.
Proven track record of working in development, validation and production operations
Knowledge of Quality Systems and QBD as they relate to GMP production operations, process optimization and process validation

Skills & Abilities
Organization and time management to deliver results
Excellent written and oral communication skills
Ability to evaluate and interpret characterisation and manufacturing data
Ability to operate in a fast-paced, multi-disciplinary industrial environment
Ability to design experimental plan to investigate deviations, out of trend
Flexibility and adaptability for re-prioritizing tasks
Ability to learn and apply new concepts
Ability to visualize / present data in order to communicate ideas, concepts and results to technical and non-technical audiences
Knowledge of statistical data analysis
Attention to detail
Working across cross functional teams to drive results
Interest in continuous improvement of processes

There is a potential for this position to require on site person-in-plant presence at CDMOs. Therefore, ability to travel is a pre-requisite
Education
Degree or equivalent higher education qualifications in a relevant science or engineering discipline.
Extensive experience in the biopharmaceutical industry leading process validation activities or process development