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Drug Product Manufacturing Lead
Job Opportunity at
Spark Therapeutics, Inc
Posted on Jun 11
The Drug Product Manufacturing Lead will oversee and manage the external drug product manufacturing vendors and sites (CMOs) providing final formulation, aseptic filling and packaging/labeling services for drug product intended for commercial and/or clinical distribution.
The incumbent will lead cross-functional programs to ensure a consistent approach across drug product manufacturing 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 Research & Development Formulation to strengthen the technical package associated with our platform container/closure system and drug product manufacturing process .
This position will also collaborate with the Supply Chain and Logistics group to ensure timely and accurate delivery of clinical and commercial drug product and further develop commercial supply chain capabilities.
Accountable for successful drug product manufacturing technology transfer execution, as planned, and ensure the required documentation is completed. Including vendor/CMO management.
As associated with technology transfer, serve as the primary point-of-contact between the site of manufacturing, the CMO vendor, and Spark for assembling and disseminating protocols, reports and other technical documentation.
Provide technical expertise for drug 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.
Strengthen the technical data package associated with the Spark platform container-closure system and manufacturing process. This includes equipment qualification, media fill/process simulation, CCIT, filter validation and other container/closure and/or manufacturing process-related studies.
Assist with the preparation of regulatory documents, such as INDs, BLAs, CBE-30s, briefing documents, etc., as associated with drug product manufacturing and related activities.
Provide technical support (man-in-plant) during drug product manufacturing activities.
Collect and assist with the analysis of drug product manufacturing process data for the identification, classification, justification and maintenance of various operational parameters.
Experience working in a GMP environment is required
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 methods
BS degree in an engineering or science discipline is required. An advanced degree is preferred.
A minimum of (10) years of experience within the pharmaceutical/biotechnology industry is required.
Process and equipment experience and/or knowledge in the areas of 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.
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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