Current Openings

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The primary goals of Analytical Sciences are: to lead the phase-appropriate optimization, qualification, verification and validation of analytical methods across the product development lifecycle from clinical to commercialization; provide support to QC in the investigation of non-conformances, invalid assays; and troubleshooting method problems. Analytical sciences will also be responsible for developing and overseeing a critical reagents management program, the reference standard program,....

- Philadelphia, PA

Under the general direction of the Drug Product Manufacturing and Facilities Lead, the Logistics and Supply Chain Lead will work across clinical and commercial products to ensure reliable, accurate, and consistent supply coordination and movement plans. S/he is responsible to build an efficient supply chain function to support the commercialization of SPK-RPE65. He/She will support the launch team with all supply chain related activities (lead time, batch size, supply scenarios, inventory, and

- Philadelphia, PA

The QC Compliance Lead will be directly responsible for the review, approval and ongoing management of all GMP quality control data. Under the general guidance of the QC Leader, s/he will work independently to ensure all data is complete, follows GMP/GDP and regulatory requirements. Develops and oversees systems and authors SOPs to manage the comprehensive and timely data review and tracking of all Quality Control data for both in-house and CRO testing. Data will include raw material release,....

- Philadelphia, PA

The Sr Quality Control Stability Specialist will be responsible for the oversight and execution of stability studies covering Spark’s growing pipeline of ground-breaking clinical and commercial programs. This role will report into the QC Stability & Systems Lead, and will also be expected to advise and assist in the overall stability program and strategy. Specific responsibilities includeGeneration and maintenance of individual study protocols,Stability study initiationStability sample....

- Philadelphia, PA

The QC Microbiology Leader is a critical member of the Quality Control & Analytical Sciences team. She/he will be responsible for directing, leading and managing the strategy and operations of the QC Microbiology and Environmental Monitoring functions at Spark Therapeutics, Inc. She/he will lead the microbiology and environmental monitoring team supporting Technical Operations. Specific responsibilities include:Lead the microbiology and environmental monitoring team, including creation of....

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