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 AS BioAssay 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.
% 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.
Education and Experience Requirements
- Trend, analyze and report method and Critical Reagent performance data, alert and advise management on issues. Review data forms and oversee instrument maintenance.
Key Skills, Abilities, and Competencies
- BS degree in the biological, biochemical or related sciences with generally 6+ years of experience in the Bio/Pharmaceutical industry or a MS degree in biological, biochemical or relates sciences with generally 3+ years of experience in the Bio/Pharmaceutical industry or PhD degree in the biological, biochemical or related sciences with generally 2+ 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
The successful candidate must demonstrate the following:
Complexity and Problem Solving
- Strong scientific and laboratory skills, with the ability to resolve and advise on technical issues of a moderate scope and develop new skills through on-the-job experience
- Detail oriented and well-organized, and capable of delivering on work assignments of moderate scope, given general instructions, where analysis involving multiple factors is required
- Effective written and oral communication skills
- The Interpersonal skills to successfully collaborate with other groups
- Ability to work efficiently in a GMP environment while exercising judgement within defined procedures/practices to determine appropriate action
- Flexible, and comfortable with a fast-paced and evolving business environment
The position requires the following, with respect to Problem Solving:
Internal and External Contacts
- The ability to identify, resolve, and/or advise on technical issues of moderate scope related to ELISAs, cell-based assays, and other assays
- The ability to carefully document experiments in a notebook, draw conclusions, and present path forward
- This position will advise and/or propose experimental design for Reference Standard characterization and qualification studies
- This position reports to, Bioassay lead of Analytical Sciences.
- This position will provide test results and project updates to the Bioassay Lead, Analytical Sciences Lead, and QC Operations Lead
- This position will acquire training from and provide training to QC Operations personnel
- This position will communicate with contract testing labs, as appropriate
- This position will communicate with personnel from other Spark departments to provide project updates, as appropriate
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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