The Scientist joining our team will be trained to perform cell-based bioassays in a GMP-regulated laboratory environment under supervision. This role contributes to critical testing activities for biologics, cell and gene therapies, vaccines, and other pharmaceutical products by generating scientifically sound, high-quality data to support product development, stability programs, and regulatory submissions
Key Responsibilities
Bioassay Execution
- Perform cell-based potency and ELISA assays.
- Maintain mammalian cell cultures and prepare reagents, standards, and controls.
- Monitor assay performance using established system suitability criteria and control trending.
Method Development & Validation
- Support assay development, optimization, qualification, validation, and method transfer activities.
- Assist with data evaluation, acceptance criteria establishment, and continuous improvement initiatives.
Data Analysis & Documentation
- Analyze data using bioassay and statistical software.
- Evaluate dose-response curves, relative potency, and assay suitability.
- Maintain accurate, complete, and GMP-compliant laboratory records.
Quality & Compliance
- Perform work in accordance with GMP, GDP, GLP, ALCOA+, and established quality systems.
- Support internal, client, and regulatory audits.
Collaboration
- Work closely with project managers, QA, study directors, and scientific staff.
- Support client interactions, technology transfers, and laboratory continuous improvement efforts.