Scientist I, Analytical Sciences - Mass Spec

Omeros•Seattle, WA

4d•$105,000 - $130,000•Onsite

About The Position

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.

Requirements

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, any other relevant 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.
Proficiency in MS Office, Word, and Excel, software is required

Nice To Haves

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.
experience with electronic laboratory notebooks, LIMS, and data analysis platforms is preferred

Responsibilities

Provide scientific and technical expertise for development and execution 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