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QC Senior Scientist-Bioassay

Date: Jul 26, 2019

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Join the Spark Team

 

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.

 

We don’t follow footsteps. We create the path.

Summary

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, The QC Senior Scientist-Bioassay 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. 

Responsibilities

Design, execute and analyze experiments in support of Bioassay and Cell-based Assay method development/optimization, with 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.  Create technical protocols and reports for Reference Standards and Critical Reagents. 

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.

 

Requirements
  • 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 2+ years of experience in the Bio/Pharmaceutical industry.
  • Experience in development and optimization of bioassays 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.
Competencies

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
  • The position requires the following, with respect to Problem Solving:

  • The ability to identify, resolve, and/or advise on technical issues of moderate scope related to ELISAs, Bioassays and other assays.
  • This position will advise and/or propose experimental design for Reference Standard characterization and qualification studies.


Nearest Major Market: Philadelphia