Scientist II, Formulations Development

Good things are happening at Omeros!

Come join our CMC Team!

This position is responsible for leading the effort on formulation development of monoclonal antibodies and small molecules to support preclinical, clinical, and the commercial phase of multiple programs. This position will conduct research, study literature, design and execute experiments, present data, write reports, and make recommendations for meeting program objectives. This position is both a hands-on laboratory-based role and requires management of outsourced projects.

Formulation development activities include excipient screening and optimization, stability testing and characterization of routes of degradation of proteins in liquid and lyophilized formulations under various stresses. Laboratory activities include buffer and protein solution preparation, pipetting and aseptic operations in a biosafety cabinet.

Activities in support of Drug Product manufacturing may be performed, which include mixing studies, process robustness and tech transfer.

Who is Omeros?

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros’ proprietary G proteincoupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.

Job Responsibilities:

• Conduct formulation development and stability studies to support various phase-appropriate antibody drug candidates ensuring compliance with all applicable regulatory guidelines.

• Run routine analytical tests such as size exclusion chromatography, sub-visible particle analysis, icIEF, CE-SDS, CEX-HPLC, viscosity, pH, protein concentration, and appearance.

• Conduct IV/SC compatibility, in-use stability and microbial challenge studies to recommend clinical and commercial dosing strategy

• Develop fit-for-purpose analytical methods to support biophysical characterization, formulation stability, and compatibility testing.

• Review technical transfer documents to support the process development and manufacturing of clinical drug substances and drug products.

• Author formulation development, comparability for process changes, and device or in-use compatibility technical documents to support regulatory filings

• Present work at group, departmental, and cross functional meetings

Essential Duties & Responsibilities

• Lead the design and execution of formulation development studies to support various phase-appropriate antibody drug candidates and small molecules ensuring compliance with all applicable regulatory guidelines.

• Run routine analytical tests such as size exclusion chromatography, sub-visible particle analysis, icIEF, CE-SDS, CEX-HPLC, viscosity, pH, protein concentration, and appearance.

• Design and execute IV/SC compatibility, in-use stability and microbial challenge studies to recommend clinical and commercial dosing strategy

• Develop fit-for-purpose analytical methods to support biophysical characterization, formulation stability, and compatibility testing.

• Author technical transfer documents to internal and external manufacturing sites. Support the process development and manufacturing of clinical drug substances and drug products

• Author formulation development, comparability for process changes, and device or in-use compatibility technical documents for internal use and to support regulatory filings

• Develop solid and liquid oral dosage forms with a strong understanding of formulation and process development in scale up

• Present work at group, departmental, and cross functional meetings