Cell Gene Therapies Specialist
1 week ago
We are seeking a highly skilled Cell Gene Therapies Specialist to join our team at Orchard Therapeutics. The successful candidate will play a key role in supporting the late-phase DS/DP MSAT team and late-phase process development, validation, and maintenance of all DS/DP manufacturing processes.
Key Responsibilities- Support commercial GMP manufacture and testing of Drug Substance (DS) and Drug Product (DP) at CDMOs, including review and approval of master & executed batch records, test records, and associated documentation.
- Provide expert compilation, review, editing, and approval of relevant documentation, such as master production records, standard operating procedures, and quality documentation.
- Support technical transfer of commercial DS/DP process manufacture within GMP and to future CDMOs, ensuring PPQ and validation status of products are maintained in line with applicable ICH, EMA, FDA, or other health authority guidance.
- Support drug product characterization analysis and establishment of cellular gene therapy product CQA and markers that predict clinical efficacy and safety.
- At least 5 years of experience in Cell and Gene Therapy in one or more areas: lentiviral vectors, plasmids & cell banks, haematopoietic stem cell biology, and characterization.
- Strong experience with risk-based approaches, such as Failure Modes and Effects Analysis.
- Proven track record of using Quality management systems, change management, deviations, and quality events.
- Experience working with third-party laboratories executing assay technology transfers and testing.
We offer a competitive salary range of £80,000 - £110,000 per annum, depending on experience, plus benefits including health insurance, pension scheme, and opportunities for professional growth and development.
About UsOrchard Therapeutics is a global biopharmaceutical company dedicated to transforming the lives of patients with rare and life-threatening diseases through innovative gene therapies. Our mission is to develop and commercialize novel treatments that address significant unmet medical needs.
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