Sr. Principal Research Associate, Formulations - Seattle, United States - Omeros

Description

Sr. Principal Research Associate, Formulations


Position Summary:
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.

Good things are happening at Omeros

Come join our CMC Team

Who is Omeros?

Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases) and cancers.

Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.

Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19.

OMS906, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial.

For more information about Omeros and its programs, visit

Education, Experience, Knowledge, & Skills Required:
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.

To apply, please email resume to and reference Job# OHG24 or apply directly thru this Career web-site.


Location:
Seattle, WA

Compensation and Benefits

The wage range for the Sr. Principal Research Associate, Formulations 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. To learn more about Omeros, please visit

Omeros is an Equal Opportunity Employer.

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