Quality Control Scientist

Organization
Spark Therapeutics
Job Location
Philadelphia, PA
Job Description

The quality control scientist will develop and validate analytical methods used for the release of gene therapy products and the evaluation of product stability, as well as prepare the protocols and reports required for documenting these activities. As required, a person in this position will develop and validate analytical methods used for the identification and release of raw materials used in the manufacturing process not outsourced for testing, and will prepare the protocols and reports required for documenting these activities. In addition, as needed, he or she will provide technical oversight to contract laboratories engaged in the testing of raw materials. The QC scientist's initial area of focus will include the following methods: PCR (qPCR, digital PCR and qualitative PCR), bioassay, gel electrophoresis (SDS-PAGE, Western Blot and Silver Stain), virus infectivity and measurement of replication competence. Additional areas of responsibility will include residual impurities for final release and in-process testing. 

RESPONSIBILITIES: 

Perform routine release testing as required for products produced both on-site and at contract manufacturers 
Assist with the authoring and reviewing of relevant quality control sections of regulatory applications 
Assist with answering of Health Authority questions and participate in Health Authority inspections 
Assist with the training of employees in developed analytical techniques and testing methods 
Assist with the development of standard operating procedures required for maintaining the QC laboratory in compliance with GxPs 
Perform activities in accordance with all applicable quality systems 
Participate in assay development in preparation for validation, analyze data and interpret results 
Execute analytical method validation and write validation protocols and reports 
Support manufacturing or laboratory deviations, as required 
Author and review out-of-specifications and in-valid test investigations 
Keep up to date with state of the art analytical methodologies and equipment

Requirements: 

QUALIFICATIONS: 

Hands on experience in performing assays such as: PCR (qualitative, quantitative, digital), Dynamic Light Scattering, mammalian cell culture techniques, tissue-culture infectious dose assays, ELISAs, gel electrophoresis (Western blots, SDS-PAGE, silver stain) 
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 
Working knowledge of statistical analysis methods used for setting validation acceptance criteria and release specifications 
Ability to develop solutions to a variety of problems of moderate scope and complexity exercising judgment within defined procedures and practices to determine appropriate action 
Ability to build productive working relationships internally and externally 
Ability to work with limited supervision; work is reviewed for soundness of judgment and overall adequacy and accuracy 
REQUIREMENTS: 

MS degree in the biological or chemical sciences with a minimum of 10 years of related laboratory experience in the pharmaceutical industry or PhD in the biological or chemical sciences with a minimum of 5 years of related laboratory experience in the Pharmaceutical industry 
Experience with biopharmaceutical products or vaccines a plus 
Some travel and weekend hours may be required

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