Quality Control Analyst - Product Stability

Spark Therapeutics
Job Location
Philadelphia, PA
Job Description

The quality control analyst, product stability 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. This person will be responsible for all phases of the stability program, including protocols, sample procurement, testing, results, reporting and escalation as appropriate. The quality control analyst must have demonstrated experience in forced and accelerated stability, follow up stability testing, stress conditions and harmonized regulatory requirements. 


Develop API and DP Stability Program for product produced for clinical and commercial use 
Identify assays required for measuring stability 
Analyze or coordinate the analysis of the required stability samples 
Manage the transfer of current stability programs from academic institution to Spark Therapeutics, including ensuring the proper technology transfer of stability indicating assays to ensure proper transition of data to Spark Therapeutics 
Develop trending program for QC release testing to support clinical and commercial programs 
Work with QC management to set API and product specification and shelf-life 
Spearhead the implementation of a reference standard program 
Support the development and validation of QC release tests as they relate to the stability program 
Support the routine release of product to meet the needs of the organization, as required 
Assist with the authoring and reviewing of relevant quality control sections of regulatory applications both for clinical and commercial release 
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, as required 
Assist with the development of standard operating procedures required for maintaining the stability program in compliance with GxPs, which may include assisting with the preparation of general QC laboratory SOPs 
Perform activities in accordance with all applicable quality systems 
Participate in assay development in preparation for validation to support the stability program 
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


Hands on experience in performing assays such as ELISAs, gel electrophoresis (Western Blots, SDS-PAGE, silver stain), HPLC column chromatography required 
Experience in PCR methodologies (qualitative, quantitative, digital) preferred 
Experience in the development of API and drug product stability programs required 
Experience in the development and management of reference standards preferred 
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 analyzing stability data for the setting of shelf life 
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 

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

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