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Posted: Wednesday, February 7, 2018 3:53 PM

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The External Manufacturing & CDMO Lead will oversee and manage the Contract Development and Manufacturing Organizations (CDMOs) providing drug substance Manufacturing, final formulation, aseptic filling and packaging/labeling services for drug substance/drug product intended for commercial and/or clinical distribution.The incumbent will lead cross-functional programs to ensure a consistent approach across CDMO sites through formalized technology transfer procedures, standardized comparability and process validation requirements, and trending of key in-process operational data.This position will collaborate with internal Spark teams (R&D, Regulatory, Technology and Technical Operations) to manage successful drug substance and drug product manufacturing outcomes for clinical and commercial manufacturing.RESPONSIBILITIES:50% Accountable for successful technology transfer execution, as planned, and ensure the required documentation is completed. Including vendor/CDMO management. As associated with technology transfer, serve as the primary point-of-contact between the site of manufacturing, the CDMO vendor, and Spark for assembling and disseminating protocols, reports and other technical documentation.30% Provide technical expertise for drug substance/product manufacturing issues that arise as part of routine manufacturing, including leading the Spark troubleshooting efforts and technical evaluation of deviations that arise during the manufacture of drug product. Provide technical support (man-in-plant) during drug product manufacturing activities. Assist with the preparation of regulatory documents, such as INDs, BLAs, CBE-30s, briefing documents, etc., as associated with drug substance/product manufacturing and related activities.20%Manage External Manufacturing and CDMO team to achieve business goals and objectives: Manage performance. Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing. Provide team members with continuous and on-going performance feedback. Hold everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by periodically reviewing individual objectives to ensure alignment to corporate and functional objectives, making adjustments if priorities have shifted. Develop team members. Help employees effectively assimilate to Spark and continually grow through challenging experiences so they can realize their full potential. Understand your employees goals, strengths and motivators. Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning, social networks and development opportunities. Foster Sparks Culture, Mission, Vision, and Values: Lead by example. Create an environment where team members thrive in our Culture by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that how they achieve performance objectives is just as important as what they accomplish.QUALIFICATIONS: Possess the ability to multitask and work independently or in a team environment with moderate supervision Possess good interpersonal and strong written/verbal communication skills Well developed skills in prioritizing, organization and time management Highly motivated and detail oriented with good organizational skills Understanding of statistical analysis methodsREQUIREMENTS: BS degree in an engineering or science discipline. An advanced degree is preferred. Generally has 15 years of experience within the pharmaceutical/biotechnology industry is required. Process and equipment experience and/or knowledge in the areas of drug substance mfg, aseptic fill, finish and packaging operations is required. Direct experience with Regulatory Inspections is required. Strong knowledge of GXP compliance as well as USP, EP, ICH and FDA guidelines. Experience working in a GMP environment is required.WHO WE ARE:Transforming Patients 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 teamSPRKTechnicalOperations

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• Location: Philadelphia

• Post ID: 62605312 philadelphia
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