Associate Scientist Associate Scientist Eurofins In-person · San Diego, CA, US about 4 hours ag
Listed on 2026-09-12
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Research/Development
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Quality Assurance - QA/QC
Associate Scientist Eurofins In-person
· San Diego, CA, US 3 days agoJob Description
The Scientist joining our team is responsible for executing and supporting the development, qualification, validation, and transfer of cell-based bioassays in a GMP-regulated laboratory environment. 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, release, stability programs, and regulatory submissions
Key Responsibilities
Bioassay Execution
- Perform cell-based potency, functional, neutralization, reporter gene, proliferation, viability, and ELISA assays.
- Maintain mammalian cell cultures and prepare reagents, standards, and controls.
- Execute GMP release, stability, characterization, and comparability studies.
- Monitor assay performance using established system suitability criteria and control trending.
Method Development & Validation
- Support assay development, optimization, qualification, validation, and method transfer activities.
- Execute studies assessing precision, accuracy, specificity, linearity, range, robustness, and system suitability.
- 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.
- Author and review protocols, reports, SOPs, and technical summaries.
- Maintain accurate, complete, and GMP-compliant laboratory records.
Quality & Compliance
- Perform work in accordance with GMP, GDP, GLP, ALCOA+, and established quality systems.
- Participate in deviations, OOS/OOT investigations, CAPAs, and change controls.
- 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.
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