Job 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.

Qualifications

Education

• BS or MS in Biology, Cell Biology, Immunology, Biochemistry, Biotechnology, Molecular Biology, or related scientific discipline.

Experience

• BS with 2–4 years or MS with 1–2 years of relevant laboratory experience in industry settings.
• Experience with mammalian cell culture, ELISA, flow cytometry, or cell-based assays preferred.

Technical Skills

Required

• Mammalian cell culture and aseptic technique
• Cell-based assay execution and troubleshooting
• Data analysis and interpretation
• Technical writing and documentation
• Proficiency with Microsoft Excel and scientific software

Preferred

• Cell-based potency, reporter gene, ADCC, and neutralization assays
• ELISA, flow cytometry, and ligand-binding assays
• qPCR/ddPCR methods
• GraphPad Prism, SoftMax Pro, PLA, JMP, or similar software
• GMP assay validation experience

Competencies

• Ability to work flexible schedules, including occasional non-standard hours, as needed to support laboratory operations and client
• Strong desire and ability to learn, adapt to, and master new laboratory techniques, technologies, and scientific methodologies
• Ability to manage multiple priorities in a fast-paced environment
• Team-oriented with the ability to work independently
• Effective written and verbal communication skills
• Excellent attention to detail and commitment to data integrity
• Strong scientific and analytical problem-solving skills
• Commitment to quality and regulatory compliance
• Strong organizational and time-management abilities

Physical Requirements

• Perform routine laboratory activities including standing, pipetting, and equipment operation.
• Work in biosafety cabinets and cell culture laboratories.
• Lift and move laboratory supplies up to 25 pounds.

Additional Information

• Position is full-time. Candidates currently living within a commutable distance of San Diego, CA are encouraged to apply.

· Excellent full time benefits including comprehensive medical coverage, dental, and vision options

· Life and disability insurance

· 401(k) with company match

· Paid vacation and holiday

• Compensation Range - $31.5/hr

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Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.