cGMP Cell Culture Scientist – Potency Assays

Us Tech Solutions; Irvine (CA); On-site; USD 70,000 - 110,000; Full time

Job summary

US Tech Solutions in Irvine, CA is seeking a GMP-lab Scientist to perform cell-based potency assays in support of the manufacture of client’s biologics and ensure timely completion of testing.

You will generate, compile and evaluate data for technical reports, review raw data and laboratory logbooks, perform cell culture and cell banking, manage reagents, and write quality systems records while adhering to EHS standards and regulatory requirements.

Qualifications

• MS or BS with 3+ / 5+ years of relevant industrial experience in a GMP environment.
• Proficiency with quality systems, data integrity, and laboratory recordkeeping.

Responsibilities

• Perform cGMP cell-based potency assays for biologics manufacturing.
• Generate, compile, and evaluate data for technical reports.
• Review and approve raw data and lab notebooks.
• Perform cell culture and cell banking.
• Manage critical reagents and supplies.
• Write quality systems records including investigations and change controls.
• Support regulatory inspections and maintain lab equipment and validation.
• Generate and update SOPs and ensure EHS compliance.

Skills

GMP experience

Education

MS in Chemistry/Biochemistry/Cell Biology

BS in Chemistry/Biochemistry/Cell Biology

Tools

Microsoft Project

Excel

Job description

US Tech Solutions in Irvine, CA is seeking a GMP-lab Scientist to perform cell-based potency assays in support of the manufacture of client’s biologics and ensure timely completion of testing.

You will generate, compile and evaluate data for technical reports, review raw data and laboratory logbooks, perform cell culture and cell banking, manage reagents, and write quality systems records while adhering to EHS standards and regulatory requirements.