Scientist I, Analytical Sciences (Mass Spectrometry)

About the role

Omeros is seeking a Scientist I, 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.

Omeros is an innovative biotechnology company that discovers, develops, and commercializes first-in-class small-molecule and protein therapeutics for large-market and orphan indications, with particular emphasis on complement-mediated diseases, cancers, and addictive or compulsive disorders.

Responsibilities

• Provide scientific and technical expertise for development and execution liquid chromatography, mass spectrometry, and other relevant analytical methods supporting CMC programs
• 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
• 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
• 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

Qualifications

A PhD in Analytical Chemistry, Pharmaceutical Sciences, or a related scientific field is required. Alternatively, a BS with 10+ years or MS with 8+ years of extensive equivalent analytical sciences experience in the pharmaceutical or biotechnology industry is acceptable.

• 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

Skills

• 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

Benefits

Omeros is proud to offer a competitive total compensation package designed to support the lives of our employees and their families. 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.

• Medical, dental, vision, life insurance, and a 401(k) plan with a company match
• Three weeks of vacation and 80 hours of sick time on an annual basis
• Twelve paid holidays throughout the calendar year
• Eligible for incentive and stock options

Pay

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.

Schedule

May encounter prolonged periods of sitting and intermittent physical activity including bending, reaching, pushing, pulling, or lifting to 40 lbs.