Scientist II, Analytical Development
Omeros has a new opportunity for a Scientist I/II to join the Analytical Development team focusing primarily on method development and characterization in support of early and late stage clinical development and commercialization of protein therapeutics (drug substance and drug product). In this role, you’ll be responsible for method development and optimization of chromatographic (HPLC, UPLC, LC-MS) and/or electrophoretic (CE-SDS, icIEF) methods, method and product characterization, and supporting formulation development and stability studies. You’ll be responsible for leading and/or supporting extensive characterization of post-translational and chemical modifications via LC-MS either independently or in collaboration with CROs. Further, this position may manage method transfers, qualifications / validations, and release and stability testing at CROs/CMOs and support global regulatory filings. Additionally, you’ll be responsible for identifying and evaluating new, orthogonal, and complimentary technologies that would expand and improve technical capabilities, efficiency, and throughput within the group.
Good things are happening at Omeros!
Come join our CMC Group!
Who is Omeros?
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement -mediated diseases and disorders of the central nervous system.
The company’s drug product OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% is marketed in the U.S. for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington’s disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.
What are your job responsibilities?
- Method development and optimization of chromatographic (HPLC, UPLC, LC-MS) and/or electrophoretic (CE-SDS, icIEF, CE-MS) methods both internally and in partnership with CROs and CMOs
- Leading and/or supporting extensive characterization of post-translational and chemical modifications via LC-MS
- Supporting tech transfer to CROs and CMOs and overseeing qualifications and/or validations of analytical methods
- Performing method and product characterization activities internally and in collaboration with CROs
- Supporting activities related to upstream and downstream process transfer and development
- Leading and/or supporting stability studies and formulation development
- Evaluating orthogonal and complimentary technologies to improve technical capabilities, efficiency, and throughput within the group
What education, experience, skills, and knowledge do you need?
You’ll need a Ph.D. in Biochemistry, Chemistry, Analytical Chemistry, or a related field with 1+ years of experience in the biotechnology and/or pharmaceutical industries. A BS or MS with 8+ years of biotechnology and pharmaceutical industry experience will also be considered.
In addition, candidates should have the following experience, skills and knowledge:
- Proven technical leadership and strong understanding of principles of chromatographic and/or electrophoretic separation techniques
- Experience characterizing physicochemical and biological properties of monoclonal antibodies, including knowledge related to chemical and post-translational modifications, degradation pathways…etc.
- Experience developing robust HPLC (SEC, RP, peptide map, CEX, etc.), CE (CE-SDS, icIEF), and/or LC-MS methods
- Experience developing and employing top-down, middle-down, and bottom-up LC-MS methods to identify and characterize post-translational and chemical modifications of antibody variants and impurities
- Experience with troubleshooting, optimizing, transferring, and qualifying/validating analytical methods
- Experience working with collaborative cross-functional teams including functional area representatives from Research, Process Development, and QC
- Familiarity with ICH, FDA, and USP guidance
- Demonstrated capability of generating and interpreting data and communicating and presenting results to peers and management
- Demonstrated technical writing and verbal communication skills with peers and management
- Demonstrated problem-solving and multi-tasking abilities
- Demonstrated ability to build and maintain positive and collaborative relationships across functional areas and with management
- A track record of successfully managing activities and relationships and meeting timelines within an organization and in collaboration with external partners
- The ability to work well in a collaborative, fast-paced, project team environment
- Detail oriented, highly adaptable, proactive, and self-motivated
Additional experience, skills, and knowledge our ideal candidate has:
As our ideal candidate, you’ll have the follow skills and knowledge:
- Experience developing stable formulations and executing stability studies for biologic and/or pharmaceutical products
- Experience and proficiency with Waters Empower software
- Experience characterizing chemical properties, purity, impurities, degradation pathways…etc. of small molecule pharmaceuticals is considered a plus
If you have the skills, knowledge and experience we are looking for, we’d love to hear from you!