Scientist I Bio-assay (AS/QC)

This role will be responsible for development, transfer, and qualification of plate-based cell-based bioassay and potency methods (including ELISAs), characterizing mechanism of action (MOA) attributes of therapeutic drug candidates, and developing new and orthogonal methods for extended characterization (such as IncuCyte, flow cytometry, or high-throughput liquid handlers). The ideal candidate has an excellent understanding of cell-based MOAs and therapeutic drug biology and should excel in cell culturing and generation of large cell banks for use in cell-based assays in development and GMP environments. This position will also contribute to tech transfer to clinical and commercial stage CRO’s/CMO’s and may contribute to managing external CRO’s who may develop and implement methods for routine testing and extended characterization. This position will be on-site at Omeros’ Seattle headquarters.

What are your job responsibilities?

• Bioassay method development, testing, transfer, qualification and validation in both development and GMP (QC) environments
• Troubleshoot method and equipment challenges, including troubleshooting and optimizing cell culture of challenging cell lines and introduction into QC environments
• Author standard test methods, technical reports summarizing analytical data, and qualification / validation reports
• Perform testing activities for in-process, release, characterization, comparability, and stability testing of clinical and commercial products
• Participate in cross-functional teams as a representative of the Bioassay (AS/QC) group
• Troubleshoot bioassay-related problems from third-party vendors, including CROs / CDMOs
• As applicable, perform investigations, including deviations, OOS/OOT/OOC results, test methods failures, and method-related root cause analyses
• Ensures laboratory equipment is calibrated and maintained in proper working order to enable compliance with GLP and/or GMP environments
• Contribute to drafting regulatory submissions (IND/IMPD, BLA/MAA, health authority responses)
• Ensure test methods development and execution activities are conducted in accordance with applicable regulatory requirements, internal policies, scientific standards, and project timelines

What education and experience do you need?

• PhD in Biochemistry, Bioengineering, Biology, or a related field with 0-3 years of experience in the pharmaceutical or biotechnology industry
• BS with 10+ years or 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 (e.g. Softmax Pro, PLA, JMP)
• Experience in maintaining and qualifying equipment required for performing potency and cell-based methods, including incubators, biosafety cabinets, plate readers, and controlled-rate freezers
• Experience with orthogonal cell-based bioassay techniques, including IncuCyte, flow cytometry, and liquid handler implementation is a plus
• Strong understanding of cell-based mechanisms of action and relationship between potency and other critical quality attributes (CQAs)
• Capable of interpreting data and communicating and presenting results to peers and management
• Experience supporting GMP release and stability testing for clinical and/or commercial biologic products is preferred
• Proficiency in MS Office, Word, and Excel software is required; experience with electronic laboratory notebooks (ELNs), LIMS, and data analysis platforms is preferred
• Some knowledge of cGMPs, ICH guidelines, regulatory expectations, data integrity requirements, and Quality Management Systems is preferred
• Experience in qualification, transfer, and validation of bioassays, internal and in management of third-party CROs / CDMOs, is preferred

Behavioral Competencies Required:

• Demonstrated ability to build and maintain positive and collaborative relationships across functional areas and with management
• Detail oriented, proactive, and self-motivated
• Must display strong analytical, problem-solving, and multi-tasking capabilities

Physical Demands Required:

• Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 40 lbs
• May encounter prolonged periods of sitting
• This position requires working with and near hazardous material
• This position may require travel up to 10% of the time