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Job Location: Philadelphia, PA
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 is also responsible for developing and overseeing a critical reagents program, the reference standard program, periodic review of analytical methods, and method performance trending and monitoring.
This role will be responsible for developing, optimizing, and validating cell-based assays within the Technical Operations Analytical Sciences organization at Spark Therapeutics facility in Philadelphia, PA. The position will also support Analytical Sciences goals by optimizing, qualifying and maintaining assay specific Critical Reagents and compound-specific Reference Standards.
- Execute experiments in support of Bioassay and Cell-based Assay method development and optimization, with minimal guidance from internal management.
- Optimize, qualify, monitor performance and maintain inventory of Reference Standard and Critical Reagents used in Quality Control Bioassays and Cell Culture.
- Participate in Bioassay and Cell-based method qualification/validation and method transfer studies.
- Create technical protocols and reports for Critical Reagents and Reference Standards.
- Provide support to complex QC investigations through experimental design, data mining and analysis, problem solving and technical writing
- Trend, analyze and report method and Critical Reagents performance data, alert and advise management on issues. Review data forms and oversee instrument maintenance.
- The successful candidate must demonstrate the following:
- 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 generally 5-7 years of experience in the Bio/Pharmaceutical industry or a MS/PhD degree in biological, biochemical or relates sciences with generally 3+ years of experience in the Bio/Pharmaceutical industry.
- Experience in development and optimization of bioassays and cell-based assays.
- Working knowledge of molecular-based (PCR) assays and virology preferred.
- Prior experience working in either a clinical development or commercial cGMP environment is required.
WHO WE ARE:
Transforming Patients 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.
How To Apply:
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