Bioassay Scientist I - GMP Cell-Based Potency

Omeros Corporation; Seattle (WA); Vor Ort; USD 105.000 - 130.000; Vollzeit

Benefits dieser Stelle

Stock options

Medical/dental/vision coverage

Vacation and paid holidays

401(k) with company match

Zusammenfassung

Omeros Corporation in Seattle, WA is seeking a Scientist I, Bioassay (AS/QC) to support potency and cell-based bioassay activities across Analytical Sciences and Quality Control. You will develop, transfer, and qualify plate-based cell-based bioassays (ELISAs) and contribute to GMP oversight for clinical and commercial products.

The role requires hands-on experience with MOA biology, cell culture, and generation of large cell banks, with opportunities to manage external CROs/CDMOs and contribute

Qualifikationen

• PhD in Biochemistry, Bioengineering, Biology, or a related field; 0-3 years pharma/biotech experience.

Aufgaben

• Bioassay method development, testing, transfer, qualification and validation in both development and GMP (QC) environments
• Troubleshoot method and equipment challenges, including cell culture of challenging cell lines and QC integration
• Author standard test methods, technical reports, and qualification/validation reports
• Perform testing for in-process, release, characterization, comparability and stability
• Collaborate with cross-functional teams as Bioassay (AS/QC) representative
• Coordinate with CROs/CDMOs for method transfer and testing
• Investigations into deviations, OOS/OOT/OOC, method failures, root cause analyses
• Ensure lab equipment calibration and maintenance for GLP/GMP compliance
• Contribute to drafting regulatory submissions (IND/IMPD, BLA/MAA)
• Ensure methods development/execution meet regulatory requirements and project timelines
• Demonstrate collaborative relationships across functions and management
• Detail oriented, proactive, and self-motivated
• Must handle hazardous materials and travel up to 10%

Kenntnisse

Cell-based bioassay development

MOA understanding

ELISA/AlphaLISA/Lumit

Data analysis (JMP/Softmax Pro)

GMP/QA knowledge

Cross-functional collaboration

Ausbildung

PhD in Biochemistry/Bioengineering/Biology or related

BS with 10+ years cell-based bioassay experience

MS with 8+ years cell-based bioassay experience

Tools

Softmax Pro

JMP

ELNs/LIMS

Incucyte

Flow cytometry

Biosafety cabinets/plate readers

Jobbeschreibung

Omeros Corporation in Seattle, WA is seeking a Scientist I, Bioassay (AS/QC) to support potency and cell-based bioassay activities across Analytical Sciences and Quality Control. You will develop, transfer, and qualify plate-based cell-based bioassays (ELISAs) and contribute to GMP oversight for clinical and commercial products.

The role requires hands-on experience with MOA biology, cell culture, and generation of large cell banks, with opportunities to manage external CROs/CDMOs and contribute