Senior Manager, Quality Control.
Orchard Therapeutics (www.orchard-tx.com), is global, fully integrated biotech company. Orchard's mission is to transform the lives of patients with rare diseases through innovative gene therapies. The company is developing ex-vivo autologous hematopoietic stem cell gene therapy to restore normal gene function in primary immune deficiencies, metabolic diseases, and hematological disorders.
Orchard has a deep pipeline of 5 clinical-stage transformative gene therapies, one approved product and multiple preclinical programs entering the clinic beginning in 2019. Data from the clinical studies show profound efficacy and multi-year durability across 5 different clinical indications with >150 patients treated. The company is anticipating regulatory submissions for 3 products over the next 3 years. The company has built capabilities and established partners to manufacture and deliver near-term products globally, with commercial opportunities in excess of $1 billion annually across the 5 lead clinical indications. In addition, Orchard plans to build internal manufacturing capabilities for world-wide patient supply.
We are seeking an enthusiastic, highly motivated, and team-oriented individual for the newly established position of Senior Manager, QC, reporting to the Director, QC, within the Global GMP Quality team, to be based at the London office. In this role, the incumbent is responsible for ensuring that laboratory processes provide high quality analytical support for manufacturing operations while ensuring compliance to protocols, cGMP, and safety regulations.
The incumbent will engage with Cell and Gene Therapy Technologies, Quality Assurance, Regulatory, and other departments on a variety of activities. Such activities include investigations associated with product deviations/OOS/OOT, analytical methods, material specifications, stability testing and review of QC data packs. The incumbent will support Orchard's cli...