Cell Bioassay Development Scientist

4 days ago


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

About the Role:

We are seeking a highly skilled Cell Bioassay Development Scientist to join our Analytical Technologies team at Frontage Laboratories. As a key member of our group, you will be responsible for developing and validating bioassays, including cell-based potency assays, ELISA, PCR-based assays, and virus infectivity assays.

Your 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.
  • Select, develop, validate, and transfer biological assays, ensuring compliance with Good Manufacturing Practice (GMP) regulations.
  • Perform method development, validation, tech transfer, product characterization, impurity profiling, routine, and stability testing across various 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, ensuring timely delivery and adherence to quality standards.

Requirements:

  • PhD in Biological Science, Biochemical Engineering, or related discipline, with 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.
  • Strong communication and leadership skills, with the ability to work with cross-functional teams.

What We Offer:

Frontage Laboratories offers a competitive compensation package, including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. The estimated annual salary for this position is $$80,000 - $110,000, depending on qualifications and experience.

We are an equal opportunity employer and welcome applications from diverse candidates.


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