Research Associate I
Seattle, WA - USA
Job Summary
We are a fast-growing and dynamic organization seeking aResearch Associate Analytical Sciencesto join our CMC team. The Research Associate Analytical Sciences will support drug substance and drug product physicochemical and biophysical testing for Analytical Sciences (AS) and CMC activities. This individual will be part of a growing team responsible for the development execution and data analyses of liquid chromatography (LC) capillary electrophoresis (CE) spectroscopic and compendial methods supporting clinical and commercial products.
The Research Associate 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 laboratory testing support for all phases of product development including clinical and commercial programs with emphasis on biologics identity purity physicochemical and compendial methods used for in-process Release Stability comparability and extended characterization testing. Responsibilities also include support and management of external CDMO and contract test lab method transfers testing troubleshooting and investigations. This role will also support internal laboratory management activities.
Good things are happening at Omeros!
Who is Omeros
Omeros is an innovative biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for both large-market and orphan indications with a focus on complement-mediated diseases cancers and addictive or compulsive disorders. Omeros lead complement inhibitor YARTEMLEA(narsoplimab-wuug) which targets the lectin pathways effector enzyme MASP-2 is FDA-approved and commercially available in the U.S. for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients aged two years and older. OMS1029 Omeros long-acting MASP-2 inhibitor has successfully completed Phase 1 clinical trials.
Under a recently announced asset purchase and licensing agreement Novo Nordisk acquired global rights to zaltenibart (formerly OMS906) an inhibitor of MASP-3 the alternative pathways key activator which is in clinical development for PNH and other alternative pathway indications along with associated intellectual property and related assets. Omeros pipeline also includes OMS527 a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder which is fully funded by the National Institute on Drug Abuse and a growing portfolio of novel recombinant antibodies targeting multidrug-resistant organisms and novel molecular and cellular therapeutic programs for oncology. For more information about Omeros and its programs visit.
What are your job responsibilities
Execute LC CE and other physicochemical testing to support CMC program activities
Develop and qualify LC CE and other physicochemical analytical methods
Author and review test methods qualification protocols and technical reports
Present experimental designs and results at AS internal cross-functional and external meetings
Support external test lab documentation and data review
Support lab management activities including equipment maintenance scheduling testing calendar scheduling inventory management shipping and receiving and waste disposal.
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
- Science related Bachelor degree or MS degree with 2 years of laboratory experience; pharmaceutical or biotechnology industry experience preferred.
- Hands-on experience with HPLC/UPLC (CEX RP SEC) CE (icIEF CE-SDS) and other spectroscopic method used for protein therapeutic testing
- Knowledge of cGMP requirements ICH guidelines regulatory expectations and data integrity requirements preferred.
- Proficiency with MS Office Word PowerPoint and Excel software is required
- Experience with laboratory notebooks is required
- Data Sciences and statistical experience with software packages such as Minitab or JMP is preferred
Behavioral Competencies Required:
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
Compensation and 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($65000 $85000). 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.
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 or contact Omeros asking for Human Resources at .
Required Experience:
IC