Scientist I Bioassay (AS/QC)

Omeros•Seattle, WA

4d•Onsite

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 position is part of a growing team responsible for developing bioassays and providing GMP oversight for clinical and commercial products. The role includes developing, transferring, and qualifying plate-based cell-based bioassays and potency methods, including ELISAs; characterizing mechanism-of-action attributes of therapeutic drug candidates; and developing orthogonal methods for extended characterization, such as IncuCyte, flow cytometry, and high-throughput liquid handlers. The scientist will also support cell culture and generation of large cell banks for cell-based assays in development and GMP environments, technology transfer to clinical and commercial CROs/CMOs, and potentially oversight of external CROs performing routine testing and extended characterization. The position is on-site at Omeros’ Seattle headquarters and may require travel up to 10% of the time.

Requirements

PhD in Biochemistry, Bioengineering, Biology, or a related field and 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 with MS Office, Word, and Excel.
Demonstrated 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.
Ability to perform intermittent physical activity, including bending, reaching, pushing, pulling, and lifting up to 40 lbs; the role may involve prolonged periods of sitting.
Ability to work with and near hazardous materials.
Ability 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.
Knowledge of cGMPs, ICH guidelines, regulatory expectations, data-integrity requirements, and Quality Management Systems.
Experience qualifying, transferring, and validating bioassays, internally and with third parties, and managing CROs/CDMOs.

Responsibilities

Develop, test, transfer, qualify, and validate bioassay methods in development and GMP (QC) environments.
Troubleshoot method and equipment challenges, including optimizing cell culture of challenging cell lines and introducing methods 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.
Participate in cross-functional teams as a representative of the Bioassay (AS/QC) group.
Troubleshoot bioassay-related issues from third-party vendors, including CROs and CDMOs.
As applicable, perform 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 method development and execution comply with applicable regulatory requirements, internal policies, scientific standards, and project timelines.
Support technology transfer to clinical and commercial CROs/CMOs and, as applicable, manage external CROs developing and implementing methods for routine testing and extended characterization.
Maintain and qualify equipment used for potency and cell-based methods.