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Scientist – In-Process Analytics and Characterization

King of Prussia, PA, US
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Summary

The Scientist will support the development, transfer, bridging, monitoring, and execution of analytical methods in support of cell and gene therapy process development and analytical testing. This role presents a unique opportunity within the Process Development Department to grow diverse technical and intellectual skills in a dynamic and fast-paced environment. We are seeking an individual who is motivated by our mission, is highly organized, and a team player that is flexible to support a range of projects within a fast-growing organization. The ideal candidate will be able to function independently or in a team setting, be goal oriented, organized, highly communicative, and able to contribute to several projects.

Responsibilities

  • Conduct method development, transfer, bridging, monitoring, and execution to support Process Development with robust in-process analytics and characterization.
  • Under minimum supervision develop, optimize, and execute analytical methods to evaluate cell and gene therapy products.
  • Maintain analytical instrumentation and contribute to the organization of reagent stocks, instruments, and documentation.
  • Design, execute and interpret experiments to meet objectives.
  • Develop presentations and effectively communicate technical results to internal technical groups.
  • Maintain an up-to-date lab notebook.
  • Perform and coordinate analytical testing in support of process development, manufacturing, cGMP investigations, and product characterization.
  • Collaborate with a diverse team to develop products for cell and gene therapy applications.
  • Draft technical reports to comply with good laboratory practices.
  • Generate, analyze, and record high-quality data using documentation, and database tools.
  • Participate in the support of analytical activities including method qualification, data trending, troubleshooting, optimization, review and reporting.
  • Review, interpret and communicates data cross-functionally within the organization.
  • Attend, participate in, and present results at cross-functional team meetings.
  • Author reports and source documentation to support regulatory filings.

Qualifications

  • Bachelor’s Degree in Biology, Biochemistry, Cell biology, Molecular Biology, Immunology, or related discipline with >8 years of relevant industry experience, a Master’s degree with a minimum of 3 years industry experience, or a PhD preferred.
  • Minimum 1 year experience in working to develop analytical methods used for process characterization or release testing in a Process/Analytical Development laboratory environment preferred.
  • Experience developing, transferring, and executing methods required.
  • Cell and gene therapy experience preferred.
  • Prior experience with in-process analytics and characterization methods including flow cytometry, plate-based assays (ie, ELISA and infectious titer), PCR-based assays (ie qPCR, dPCR, ddPCR), and other common analytics highly desired.
  • Demonstrated ability to conduct and interpret experiments to meet technical objectives
  • Excellent attention to detail, strong documentation skills, and ability to communicate technical findings effectively both written and verbal
  • A proven ability to collaborate with team members to complete projects in an efficient and timely manner.

Scientist – In-Process Analytics and Characterization

King of Prussia, PA, US
Apply Now >