The primary goals of Analytical Sciences are: to lead the phase-appropriate optimization, qualification, verification and validation of analytical methods across the product development lifecycle from clinical to commercialization; provide support to QC in the investigation of non-conformances, invalid assays; and troubleshooting method problems. Analytical sciences will also be responsible for developing and overseeing a critical reagents management program, the reference standard program, periodic review of analytical methods, and method performance trending and monitoring.
Reporting to the QC BioAssay and Cell Culture Lead, s/he is responsible for optimizing, qualifying and maintaining assay specific Critical Reagents and compound specific Reference Standards. The role will also support Analytical Sciences Departmental goals by participating in development, optimization, qualification and validation of analytical assays within the Technical Operations Analytical Sciences organization at Spark Therapeutics’ facility in Philadelphia, PA.
• Optimize, qualify and maintain inventory of Reference Standard and Critical Reagents used in Quality Control.
• Create technical protocols and reports for Critical Reagents.
• Trend and report method and Critical Reagents performance data
• Provide support to QC investigations through experimental design, data mining and analysis, problem solving and technical writing
• Execute experiments in support of Bioassay method development and optimization, with guidance from internal management
• Participate in Cell-based method qualification/validation and method transfer studies
• Strong scientific and technical skills, capable of problem solving
• Detail oriented and well-organized
• Strong written and oral communication skills
• The Interpersonal skills to successfully collaborate with other groups
• Flexible, and comfortable with a fast-paced and evolving business environment
•BS degree in the biological, biochemical or related sciences with a minimum of 4 years of experience in the Bio/Pharmaceutical industry -OR- a MS/PhD degree in biological, biochemical or relates sciences with a minimum of 2+ years of experience in the Bio/Pharmaceutical industry.
•Working knowledge of virology or cell-based assays.
•Working knowledge of molecular-based assays.
•Prior experience working in either a clinical development or commercial cGMP environment is preferred.
• Evening and weekend hours may occasionally be required.
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.