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QC Raw Materials Associate
Job Opportunity at
Spark Therapeutics, Inc
Posted on Jun 8
The QC Raw Materials Associate will be responsible for executing activities required for the cGMP compliant program (in compliance with USP/PhEur/JP) for sampling and testing of raw materials and components used in the manufacture of biological DS & DP for clinical phase and commercial gene therapy products at Spark Therapeutics’ site in Philadelphia, PA. This role will encompass the execution of RM management and testing, assisting in the implementation raw material-management software, and tracking and trending of raw material data. The Raw Material Scientist will follow the sample submission process and will also work closely with contract testing laboratories to coordinate outsourced raw material testing and data review. This person will work closely with an external warehouse to manage the storage, sampling, and reporting of raw materials stored off site. This person will perform non-conformance (OOT/OOS) investigations, CAPAs, and change controls associated with both insourced and outsourced raw material testing. This person will be the department representative for the raw material program in interdepartmental meetings and will participate in regulatory audits. The position will also be responsible for participating in training for other departmental scientists who perform in-house raw material and chemical testing.
Execute the GMP raw material program. Maintain relationship with contracting testing laboratories and external warehouse facility.
Coordinate sample testing, review data, trend data and investigate non-conformances.
Complete CAPA and Change Controls in a timely manner to support the department.
Hands on experience
Raw Material analytical expertise
Responsible for analyzing and trending analytical data
Ability to multi-task and work in a regulated environment
Ability to set and meet agreed upon timelines
Excellent communication skills, both oral and written
Ability to develop solutions to a variety of problems of moderate scope and complexity exercising judgment and decision making within defined procedures and practices to determine appropriate action
Possess the skill to build productive working relationships with employees from various departments, both internally and externally
Ability to work with limited supervision; work is reviewed for soundness of judgment and overall adequacy and accuracy
BS or MS degree in the biological or chemical sciences with generally 3-5+ years of related experience in the Pharmaceutical industry.
Experience with biopharmaceutical products, biologics or vaccines required.
Must have GMP experience.
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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