Cmc Statistics Jobs in Bothell, WA (NOW HIRING)

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.
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 pathway's 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 pathway's 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 www.omeros.com.
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 ($65,000 - $85,000). 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.