Sr. Principal Research Associate, Formulations

Conduct formulation development activities to support various phase-appropriate antibody drug product, drug substance and placebo formulation development. Perform stability studies under thermal, agitation and light stress conditions to evaluate the stability of the antibody drug products and placebo formulations to identify the paths and rate of degradation. Recommend appropriate long term storage conditions and shelf life for the drug products based on the stability study data. Run analytical tests such as appearance (color and clarity) sub-visible particle analysis, size exclusion chromatography (SEC), icIEF, cIEF, CE-SDS, CEX-HPLC, HPLC-ELSD, Intact mass spectroscopy, viscosity, pH, and protein concentration. Conduct in-use compatibility and stability studies in infusion bags to recommend clinical and commercial dosing strategy. Contribute to writing technical transfer documents for the process development and manufacturing of clinical drug substances and drug products. Author formulation development and compatibility technical documents for internal use and to support regulatory filings. Present work at group, departmental, and cross functional meetings. Position may include additional duties that utilize the required skills.

Requires a Master’s or foreign equivalent degree in Chemistry, Pharmaceutical Science, Bioengineering, or a related field, and two years of experience in:
• Performing High Performance Liquid Chromatography (HPLC) and Ultra Performance Liquid Chromatography (UPLC) techniques including Size-Exclusion Chromatography (SEC), Reverse Phase Liquid Chromatography (RP), Ion exchange Chromatography (IEX), Hydrophobic Interaction (HIC), affinity chromatography, and Liquid Chromatography with a Evaporative Light Scattering Detector (LC-ELSD), as well as performing electrophoretic techniques including Imaged capillary isoelectric focusing (icIEF), molecular weight Capillary electrophoresis sodium dodecyl sulfate (MW CE-SDS) and Capillary isoelectric focusing (cIEF), and biophysical techniques, including Differential Scanning Calorimetry (DSC), dynamic light scattering (DLS), Ultraviolet-visible (UV-Vis), fluorescence, High Accuracy (HIAC) and MicroFlow imaging for protein characterization;

• Using dialysis, Tangential Flow Filtration (TFF), Karl Fisher titration, and Near-infrared (NIR), for protein and antibody formulations preparation, processing, and characterization;

• Performing formulation development activities and IV admixture compatibility for monoclonal antibodies and novel protein-based molecules; and

• Planning and executing formulation screening and formulation stability studies for proteins and antibodies.

The wage range for this position is $114,828 to $123,200. 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 bonus and stock options.

Position: Sr. Principal Research Associate, Formulations
Location: Omeros Corporation, Seattle, WA

To apply, please email resume to recruiting@omeros.com and reference Job# OHG24.