New
Scientist II
Spectraforce Technologies | |
United States, California, Irvine | |
Oct 15, 2026 | |
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Position Title: Scientist II
Work Location: Irvine, CA 92612 Assignment Duration: 12 Month Work Arrangement: 100% Onsite Key Responsibilities: * Perform cGMP cell-based potency assays testing in support of the manufacture of our organization's biologics products. Responsible for the timely completion of assigned laboratory testing. * Generate, compile, and evaluate data for technical reports to support commercial and clinical supplies. * Review and approve raw data and laboratory logbooks/worksheets. * Perform cell culture and cell banking. * Manage critical reagents and supplies. * Write quality systems records including laboratory investigations, change controls, non-conformances. * Support regulatory inspections where needed. * Ensure that all lab equipment is used and maintained correctly. Support lab equipment validation and equipment preventive maintenance. * Generate and update SOPs. * Adhere to and supports all EHS standards, procedures and policies. * Understand regulations and business processes required to maintain laboratory data integrity. * Maintain and comply with laboratory documentation and computerized systems data integrity requirements. Qualifications & Experience: * MS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 3+ years of relevant industrial experience or BS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 5+ years of relevant industrial experience. * Proficiency in quality systems, Microsoft Project, and Excel. * Experience in a GMP-regulated environment. * Experience in bioassays, Chemi-ECL ELISA, PCR and automation preferred. * Experience with aseptic cell culture and cell banking preferred. Top 3-5 skills, experience or education required for this position: Experience in a GMP regulated environment. Experience in bioassays, Chemi-ECL ELISA, PCR and automation preferred. Experience with aseptic cell culture and cell banking preferred. Proficiency in quality systems Laboratory investigations, change controls, non-conformances. | |
Oct 15, 2026