Scientist I Bioassay (AS/QC)
About The Position
Omeros is seeking a Scientist I, Bioassay (AS/QC) to provide strategic and technical support for potency and cell-based bioassay activities across Analytical Sciences and Quality Control. The role is part of a growing team responsible for developing bioassays and providing GMP oversight for assays supporting clinical and commercial products. It is based on-site at Omeros’ Seattle headquarters. The scientist will develop, transfer, qualify, and validate plate-based cell-based bioassay and potency methods, including ELISAs; characterize mechanism-of-action attributes of therapeutic drug candidates; and develop orthogonal methods for extended characterization, such as IncuCyte, flow cytometry, and high-throughput liquid handlers. The position requires cell-culture expertise, including generating large cell banks for assays used in development and GMP environments. The scientist will contribute to technology transfer to clinical and commercial CROs/CMOs and may help manage external organizations developing and implementing methods for routine testing and extended characterization. The role includes performing analytical testing and investigations, preparing methods and reports, supporting regulatory submissions, and ensuring that method development and execution comply with applicable regulations, internal policies, scientific standards, and project timelines.
Requirements
- PhD in Biochemistry, Bioengineering, Biology, or a related field, with 0–3 years of pharmaceutical or biotechnology industry experience; alternatively, a BS with 10+ years or an MS with 8+ years of extensive cell-based bioassay experience in the pharmaceutical or biotechnology industry.
- Strong hands-on experience developing cell-based bioassays, plate-based potency assays (e.g., ELISA, AlphaLISA, Lumit), and large mammalian cell banks.
- Experience with potency-assay statistical software such as Softmax Pro, PLA, or JMP.
- Experience maintaining and qualifying equipment used for potency and cell-based methods, including incubators, biosafety cabinets, plate readers, and controlled-rate freezers.
- Strong understanding of cell-based mechanisms of action and the relationship between potency and other critical quality attributes (CQAs).
- Ability to interpret data and communicate and present results to peers and management.
- Proficiency in MS Office, Word, and Excel.
- Ability to build and maintain positive, collaborative relationships across functional areas and with management.
- Detail-oriented, proactive, and self-motivated, with strong analytical, problem-solving, and multitasking capabilities.
- Must be able to perform intermittent physical activity, including bending, reaching, pushing, pulling, or lifting up to 40 pounds; may sit for prolonged periods and work with and near hazardous material.
- May be required to travel up to 10% of the time.
Nice To Haves
- Experience with orthogonal cell-based bioassay techniques, including IncuCyte, flow cytometry, and liquid-handler implementation.
- Experience supporting GMP release and stability testing for clinical and/or commercial biologic products.
- Experience with electronic laboratory notebooks (ELNs), LIMS, and data-analysis platforms.
- Some knowledge of cGMPs, ICH guidelines, regulatory expectations, data-integrity requirements, and Quality Management Systems.
- Experience qualifying, transferring, and validating bioassays, both internally and through management of third-party CROs/CDMOs.
Responsibilities
- Develop, test, transfer, qualify, and validate bioassay methods in development and GMP (QC) environments.
- Troubleshoot method, equipment, and cell-culture challenges, including optimizing challenging cell lines and introducing them into QC environments.
- Author standard test methods, technical reports summarizing analytical data, and qualification and validation reports.
- Perform in-process, release, characterization, comparability, and stability testing for clinical and commercial products.
- Represent the Bioassay (AS/QC) group on cross-functional teams.
- Troubleshoot bioassay-related problems from third-party vendors, including CROs and CDMOs.
- As applicable, conduct investigations involving deviations, OOS/OOT/OOC results, test method failures, and method-related root-cause analyses.
- Ensure laboratory equipment is calibrated and maintained in proper working order to support GLP and/or GMP compliance.
- Contribute to drafting regulatory submissions, including IND/IMPD, BLA/MAA, and health authority responses.
- Ensure test-method development and execution comply with applicable regulatory requirements, internal policies, scientific standards, and project timelines.
- Develop and qualify plate-based cell-based bioassay and potency methods, characterize therapeutic drug candidates’ mechanisms of action, and develop orthogonal characterization methods.
- Support technology transfer to clinical and commercial CROs/CMOs and, as applicable, help manage external CROs developing or implementing methods.
Benefits
- Medical, dental, vision, and life insurance.
- 401(k) plan with company match.
- Three weeks of vacation accrued annually.
- 80 hours of sick time accrued annually.
- Twelve paid holidays per calendar year.
- Eligible for incentive compensation and stock options.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Ph.D. or professional degree
