28 days old
2017-11-132017-12-13

Scientist I/Scientist II, Analytical Development

Omeros Corporation
Seattle, Washington 98119
  • Job Type
    Employee
  • Job Status
    Full Time

Scientist I / Scientist II, Analytical Development

 

Omeros has a new opportunity for a development and characterization scientist to join the Analytical Development team. This position will be responsible for supporting early and late stage clinical development and commercialization of monoclonal antibody therapeutics.

 

In this role, you’ll be responsible for method development and optimization of chromatographic (HPLC, UPLC) and/or electrophoretic (CE-SDS, cIEF, icIEF) methods, lead method and product characterization, and you’ll support formulation development and stability studies. Further, this position will manage method transfers, qualifications / validations, and release and stability testing in partnership with CRO’s/CMO’s in support of global regulatory filings. You’ll also evaluate new tools and orthogonal and complimentary technologies to expand and improve technical capabilities, efficiency, and throughput within the group. Additionally, you may have opportunities to manage a direct report.

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?

  • Be a technical leader in method development and optimization of chromatographic (HPLC, UPLC) and/or electrophoretic (CE-SDS, cIEF, icIEF) both internally and in partnership with CROs and CMOs

  • Manage tech transfer and qualification and/or validation of analytical methods CROs and CMOs

  • Perform method and product characterization activities internally and in collaboration with CROs

  • Evaluate orthogonal and complimentary technologies to improve technical capabilities, efficiency, and throughput within the group

  • May be responsible for leading and managing a direct report

Requirements

What education, experience, skills, and knowledge do you need?

You’ll need to have a BS or MS in Chemistry, Biochemistry, Analytical Development, or a related field with 10+ years of biotechnology and/or pharmaceutical industry experience; a Ph.D. with 2+ years of experience will also be considered. In addition, candidates will need to have the following experience, skills and knowledge:

  • Strong understanding of technical principles of chromatographic and/or electrophoretic methods

  • 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.) and/or CE-based (CE-SDS, cIEF, icIEF) methods

  • 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, proactive, and self-motivated

     

Additional experience our ideal candidate has:

As our ideal candidate, you’ll need the following additional experience:

  • Experience developing stable formulations and executing stability studies for biologic and/or pharmaceutical products

  • Experience and proficiency with Waters Empower software

  • Experience developing, optimizing, troubleshooting, and interpreting results from LC-MS assays

     

If you have the skills, knowledge and experience we are looking for, we’d love to hear from you!

 

Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.

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 hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000.

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Scientist I/Scientist II, Analytical Development

Omeros Corporation
Seattle, Washington 98119

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Scientist I/Scientist II, Analytical Development

Omeros Corporation
Seattle, Washington

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