Cell Bioassay Development Scientist
4 days ago
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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