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.

50% 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.

20% 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

15% Participate in Bioassay and Cell-based method qualification/validation and method transfer studies. Draft method-specific Validation Protocols and Reports.

10% Provide support to complex QC investigations through experimental design, data mining and analysis, problem solving and technical writing.

5% 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

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 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