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.
Reporting to the QC BioAssay and Cell Culture Lead, s/he 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 compound-specific Reference Standards and assay-specific Critical Reagents.
Describe the essential daily job functions and include % of time spent on each.
% of Time
Job Function and Description
- Design, execute and analyze experiments in support of Bioassay and Cell-based Assay method development/optimization, with guidance / minimal guidance from internal management. Draft method-specific development reports and SOPs.
- Optimize, qualify, monitor performance and maintain inventory of Reference Standard and Critical Reagents used in Quality Control Bioassays and Cell Culture.
- Testing QC reagents and samples
- Participate in Bioassay and Cell-based method qualification/validation and method transfer studies. Draft method-specific Validation Protocols and Reports.
- 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 Reagent performance data, alert and advise management on issues. Review data forms and oversee instrument maintenance.
- BS degree in the biological, biochemical or related sciences with generally 10+ years of experience in the Bio/Pharmaceutical industry or a MS degree in biological, biochemical or relates sciences with generally 5+ years of experience in the Bio/Pharmaceutical industry or PhD degree in the biological, biochemical or related sciences with generally 3+ years of experience in the Bio/Pharmaceutical industry
- Experience in development and optimization of ELISAs and cell-based assays
- Experience in the design and optimization of potency and infectivity assays for AAV gene therapy products preferred
- Working knowledge of molecular-based (PCR) assays and virology preferred
- Prior experience working in either a clinical development or commercial cGMP environment is required
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
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