Scientist I, Analytical Sciences - Mass Spec

Omeros is seeking a Scientist, Analytical Sciences (Mass Spectrometry) to provide strategic and technical leadership for biological mass spectrometry‑related activities across Analytical Sciences and Quality Control. This individual will be part of a growing team of scientists responsible for the development and GMP oversight of mass spectrometry and liquid chromatography assays supporting clinical and commercial products. The scientist will develop, execute, and manage methods used for clinical and commercial testing to support CMC, Discovery, Quality Assurance, Regulatory Affairs, and corporate objectives. The scope of this role includes mass spectrometry and liquid chromatography related support for all phases of product development, including clinical and commercial programs, with emphasis on biologics peptide mapping, intact mass determination, mass spectrometry (MS) related host cell protein (HCP) quantification, and other analytical methods used to assess extended characterization, product quality, biological activity, and release/stability attributes. Responsibilities Provide scientific and technical expertise for development and execution of liquid chromatography, mass spectrometry, and other relevant analytical methods supporting CMC programs As applicable, author and review relevant test methods, technical reports, structural characterization sections of regulatory filings (IND/IMPD and BLA/MAA), briefing packages, responses to health authority questions, validation reports, comparability assessments, and extended characterization studies Represent Mass Spectrometry and liquid chromatography expertise in meetings, and technical discussions with external partners Perform testing activities for in‑process, release, characterization, comparability, and stability testing of clinical and commercial products As needed, provide technical oversight of external contract manufacturing organizations, contract testing laboratories, and other third‑party partners performing mass spectrometry (MS) and liquid chromatography (LC)‑related activities Support product specification setting for MS and LC‑related quality attributes As applicable, perform investigations, including deviations, OOS/OOT/OOC results, test methods failures, and method‑related root cause analyses Develop LC and MS related test methods strategy in conjunction with analytical method development, process development, manufacturing, formulation, Quality Assurance, and Regulatory Affairs teams Drive continuous improvement initiatives to improve test methods robustness, reduce variability, strengthen data integrity, improve method performance, and support operational excellence Ensure test methods development and execution activities are conducted in accordance with applicable regulatory requirements, internal policies, scientific standards, and project timelines Education and Experience PhD in Analytical Chemistry, Pharmaceutical Sciences, or a related scientific field BS with 10+ years or MS with 8+ years of extensive equivalent analytical sciences experience in the pharmaceutical or biotechnology industry Strong hands‑on expertise with HPLC/UPLC (CEX, RP, SEC), LC‑MS instrumentation, specifically in protein and antibody characterization Design, develop, and optimize LC‑MS/MS methods for identification and quantification of macromolecules (e.g., intact mass, peptide mapping, PTM analysis) Maintain, calibrate, and troubleshoot high‑resolution mass spectrometers and HPLC/UPLC systems (e.g., QTOF, Orbitrap) Analyze complex MS datasets, including proteomics data with BioPharma and Proteome Discoverer, to provide insights for biologics structural characterization Maintain accurate records, prepare technical reports, test methods, and other documentation and present findings in written or verbal formats Hands‑on experience on sample preparation for mass spectrometric and liquid chromatographic analyses by advanced mass spectrometric and liquid chromatographic methodologies, interpretation (qualitative and quantitatively) of the experimental data, and summarizing results for review and report preparation Some knowledge of cGMPs, ICH guidelines, regulatory expectations, data integrity requirements, and Quality Management Systems is preferred 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, LIMS, and data analysis platforms is preferred Behavioral Competencies Demonstrated ability to build and maintain positive, collaborative relationships with management, peers, subordinates, cross‑functional teams, and external contract organizations Strong scientific judgment and ability to make sound technical decisions in relevant situations Excellent written and oral communication skills, with the ability to clearly communicate complex scientific concepts to technical and non‑technical audiences Strong organizational, problem‑solving, and decision‑making skills with the ability to manage multiple priorities in a fast‑paced environment Self‑motivated and detail‑oriented, with the highest integrity and commitment to quality, compliance, and scientific excellence Physical Demands Intermittent physical activity including bending, reaching, pushing, pulling, or lifting to 40 lbs May encounter prolonged periods of sitting This position requires working with and near hazardous material Compensation and Benefits Omeros offers a competitive total compensation package. The wage scale for this position is $105,000 – $130,000. Salaries will be determined based on knowledge, skills, education, and experience relevant to the role. Employees are offered medical, dental, vision, life insurance, and a 401(k) plan with a company match. Employees accrue three weeks of vacation and 80 hours of sick time on an annual basis and receive twelve paid holidays throughout the calendar year. This position is eligible for incentive and stock options. Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes. It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e‑mail to View email address on click.appcast.io or contact Omeros, asking for Human Resources, at View phone number on click.appcast.io. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills, and/or abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. #J-18808-Ljbffr Omeros Corporation