Senior Research Scientist

5 days ago


Exton, Pennsylvania, United States Frontage Laboratories Full time
Job Summary

We are seeking a highly skilled Senior Research Scientist to join our Analytical Technologies group at Frontage Laboratories. As a key member of our team, you will be responsible for developing and implementing bioassays to support product characterization, release, and stability studies in a GMP setting.

Key Responsibilities
  • Develop and apply molecular biological methods, immunoassays, and other state-of-the-art analytical technologies to analyze and characterize cell and gene products, biotherapeutic proteins, their conjugates, and variants.
  • Independently select, develop, validate, and transfer biological assays, including cell-based potency assays, ELISA, qPCR-based assays, virus infectivity assays, etc.
  • Perform method development, validation, tech transfer, product characterization, impurity profiling, routine, and stability testing across varieties of biological products.
  • Prepare project proposals, protocols, reports, Certificate of Analysis, investigation reports, and generate cGMP documents.
  • Maintain qualification and compliance of instruments and conduct technical and instrumental troubleshooting.
  • Manage projects from initiation to completion and ensure they are on time and meeting pre-established quality standards.
  • Author method SOPs, development reports, qualification/validation reports to support method transfer to GMP QC.
  • Perform analytical tests to support method development, DS/DP characterization, PD studies, lot release, and stability testing of drug substance and drug products.
Requirements
  • PhD, MS, or BS in Biological Science, Biochemical Engineering, or related discipline.
  • 0-2 years' relevant industrial GMP testing or analytical development experience for biologics or cell and gene therapy products, or
  • MS with 2-4 years' GMP testing or analytical development experience for biologics or cell and gene therapy products, or
  • BS with 3-5 years' GMP testing or analytical development experience for biologics or cell and gene therapy products.
  • Excellent organization and planning skills.
  • Experience in virus-vector based biotechnology or virology is preferred but not required.
  • Excellent communication skills, with the ability to work with individuals in wide-ranging teams at all levels and the ability to lead and influence.


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