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Spark Therapeutics, Inc
Posted on Nov 20
As part of the Technical Operations, Analytical Sciences organization at Spark Therapeutics’ facility in Philadelphia, PA, this role will be responsible for optimizing, validating, and transferring separations and related methods that support Spark products. In addition, this person will develop and conduct qualifying activity related to Critical Reagents and Reference Standards.
The primary goals of Analytical Sciences group are to lead the phase-appropriate optimization, and qualification of analytical methods across the product development lifecycle from clinical to commercialization, and provide support to QC in assay transfers, the investigation of non-conformances and invalid assays, and troubleshooting method problems. Analytical sciences will also be responsible for developing and overseeing a critical reagents and reference standard management program, periodic review of analytical methods, and method performance trending and monitoring.
Develop protocols for method validations and transfer studies; write Method SOPs and reports; oversee testing and transfer activities; and participate in data generation as needed
Interface with R&D on the development of new analytical methods for Quality Control, and oversee the creation and/or implementation of these methods in support of Spark’s clinical development pipeline. Lead method improvements and investigations in QC by designing/conducting experiments, and associated activity
Develop procedures for characterization of reference material, and to provide understanding of the effect of molecular changes on product activity
Evaluate assay results for method performance and reference standard trending
Select and evaluate appropriate critical reagents for new assays, write qualification procedures and reports for these reagents, and perform reagent qualifications
Write sections or provide input to regulatory submissions and responses. Assist in preparation for GMP audits
Strong knowledge of HPLC, electrophoretic, and spectrometric techniques for proteins
Strong written / oral communication, and organizational skills
Detail-oriented, with understanding of GMP requirements
Team player, capable of successfully collaborating with Quality Control Operations and Quality Assurance
Capable of directing activities of other scientists in the organization
Interested in working in a fast-paced and evolving business environment
MS degree in analytical biochemistry, protein chemistry, or related field with a minimum of 6 years of experience or PhD degree in analytical biochemistry or related field with a minimum of 4 years of experience in the Bio/Pharmaceutical industry.
Experience in development and optimization of biophysical methods.
Prior experience working in either a clinical development or commercial cGMP environment is strongly preferred.
WHO WE ARE:
Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.
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