Research Associate I

Omeros•Seattle, WA

13d•$65,000 - $85,000•Onsite

About The Position

We are a fast-growing and dynamic organization seeking a Research Associate, Analytical Sciences to 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.

Requirements

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
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

Nice To Haves

Data Sciences and statistical experience with software packages such as Minitab or JMP is preferred

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