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Research Associate, ELISA

King of Prussia, PA, US
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Summary

The Research Associate will execute testing with regards to the analytical method development for cell and gene therapy products with a multidisciplinary R&D team focused on developing innovative assays for cell and gene therapy products.

Responsibilities

  • Execution of testing in an R&D & GMP laboratory
  • Collaborate with a diverse team to develop new assays for cell and gene therapy applications.
  • Conduct cell-based, molecular and analytical assays
  • With supervision design, execute and interpret experiments to meet R&D objectives.
  • Develop presentations and communicate technical results to internal technical groups.
  • Maintain accurate laboratory records and draft technical reports to comply with good laboratory practices. and standard operating procedures.
  • Work with scientists to transition assays to GMP
  • Generate, analyze, and record high-quality data using documentation, and database tools.
  • Maintain laboratory records and contribute to laboratory organization and maintenance.
  • Independently develop, optimize, and qualify analytical methods to characterize viral vector and cell therapy products.
  • Perform and coordinate analytical testing in support of process development, cGMP investigations and product characterization.
  • Designs and executes experiments to characterize RCT drug product for protein expression, cell metabolism and lipid structure and function.
  • Identifies critical product quality attributes in RCT drug product through forced degradation and structure-function related studies.
  • Characterize process and product related impurities in cell product and viral vector in collaboration with process development teams.
  • Evaluate new technologies to assess biophysical and biochemical properties of RCTs.
  • Participate in the support of analytical activities related to analytics including method qualification, data trending, troubleshooting, optimization, review and reporting.
  • Reviews, interprets 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, Molecular Biology, Immunology or related discipline
  • Minimum 3 years’ experience in cell and molecular biology, biochemistry, chemical engineering, or a related field with relevant laboratory experience, pharmaceutical or biotechnology industry preferred.
  • Minimum 3 year’s of experience with ELISA and similar techniques
  • 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.
  • Capability and desire to work in a dynamic, fast-paced, innovative environment
  • Prior experience with cell culture, ELISA and flow cytometry techniques is highly desirable
  • Prior exposure to GMP, ISO regulated environment is a desirable
  • Independently troubleshoot experiments and contribute to research directions
  • Understanding of compliance and cGMP considerations.

Research Associate, ELISA

King of Prussia, PA, US
Apply Now >