Scientist I, Analytical Sciences - Mass Spec

include:

• 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

• 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.
• 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

• 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

• 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

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.

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.

To learn more about Omeros, please visit www.omeros.com.

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 hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000.

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.