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Scientist/Sr. Scientist – Bioassay Analytical Development

King of Prussia, PA, US
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Summary

The Scientist will support the development, validation, transfer of cell-based, potency analytical methods in support of cell and gene therapy product development and analytical testing. This role presents a unique opportunity within the Testing and Analytical Services 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 bioassay method development to evaluate the functionality and potency of cell and gene therapy products.

· Under minimum supervision develop, optimize, and qualify analytical methods to characterize cell therapy products.

· Maintain analytical instrumentation and contribute to the organization of reagent stocks, cell banks, and instrument documentation.

· Design, execute and interpret experiments to meet R&D 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, or a Master’s degree with a minimum of 3 years industry experience preferred.
  • Minimum 1 year experience in working to develop analytical methods used for process characterization or release testing in a GxP laboratory environment preferred.
  • Experience developing and qualifying potency methods required.
  • Cell and gene therapy experience preferred.
  • Prior experience with human cell isolation, aseptic technique, cell culture and banking, ELISA/MSD/ELISpot, or flow cytometry is 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/Sr. Scientist – Bioassay Analytical Development

King of Prussia, PA, US
Apply Now >