Quality Control Associate​/Sr Quality Control Associate

We are a fast-growing and dynamic organization seeking a
Quality Control Associate / Sr Quality Control Associate
to join our CMC team.

The role coordinates release and stability testing, reviews laboratory data packets and reports, and works with vendors and internal Quality partners to resolve documentation gaps, deviations, OOS/OOT results, and CAPA actions. Level and degree of independence will reflect experience and demonstrated capabilities.

This position will be primarily responsible for QC data review of data packets and reports from external vendors. The role has hands-on experience with performing one or more physicochemical methods such as chromatographic methods (SEC, RP-HPLC, peptide map, CEX), electrophoretic methods (CE-SDS, SDS-PAGE, and icIEF), and compendial assays (pH, osmolality, endotoxin, sterility) and will be familiar with method troubleshooting. This role will also assist the broader QC team with GMP investigations and oversight, and additionally, will assist with non-GMP in-lab support for deviations and critical reagent management.

This position will be on‑site at Omeros’ Seattle headquarters.

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.

OMS
1029, Omeros’ long‑acting MASP‑2 inhibitor, has successfully completed Phase 1 clinical trials.

Under an asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS
906), 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 OMS
527, 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

• Review and manage QC data to support GMP manufacturing
• Assist in overseeing release and stability testing of clinical and commercial drug substance and drug product at CROs and CMOs
• Assist in overseeing investigations, deviations, CAPAs, and OOS related to release and stability testing
• Review data quality and integrity and data trending
• Manage material inventories and shipment and receipt of material to and from external vendors
• Perform non‑GMP in‑lab testing to support internal investigations and critical reagent qualification or extension, documenting results under applicable protocols and procedures
• Ensuring compliance with all applicable regulatory guidelines, including relevant method USP and ICH guidelines, and relevant GMP codes of federal regulation
• For Sr QC Associate level, manage tech transfer, method validation, lifecycle management, troubleshooting, and remediation of analytical methods at CROs and CMOs, including potential travel to external testing laboratories

• BS or MS in Chemistry, Biochemistry, Analytical Chemistry or…