Scientist, Potency ELISAs and Bioassays
Omeros is looking for a Scientist to join the Analytical Development and Quality Control group to develop, transfer, qualify, and validate potency bioassays in support of clinical development and commercialization of antibody therapeutics. The Scientist will develop and implement biological potency methods for release, stability and characterization testing, contribute to tech transfer to clinical and commercial stage CRO’s/CMO’s, and provide input to and manage external CRO’s who may develop and implement methods for routine testing and extended characterization. The Scientist may also have opportunities to contribute to the development and implementation of impurity ELISAs and analytical HPLC and/or CE methods to monitor physicochemical quality attributes for both protein and small molecule therapeutics.
Good things are happening at Omeros!
Come join our CMC Group!
Who is Omeros?
Omeros is a Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system.
Part of its proprietary PharmacoSurgery® platform, the company's first drug product, OMIDRIA® (phenylephrine and ketorolac injection) 1%/0.3%, was broadly launched in the U.S. in April 2015. OMIDRIA is the first and only FDA-approved drug (1) 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 and (2) that contains an NSAID for intraocular use. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has 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 proprietary G protein-coupled receptor, or GPCR, platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development, and a platform used to generate antibodies.
What are your job responsibilities?
• Development of potency ELISAs for protein therapeutics and interpreting data
• Performing method transfers, qualifications, and validations
• Troubleshooting typical method and equipment challenges
• Assisting in trouble-shooting CMC related problems from CRO’s/CMO’s
• Assisting in investigations involving data generated internally and by CRO’s/CMO’s
• Ensuring laboratory equipment is calibrated and maintained in proper working order to enable compliance with GLP and/or GMP environments
• Participating in cross-functional teams as a representative of the Analytical Development group
• Present data at internal meetings
• Write standard test methods, technical reports summarizing analytical data, and qualification/validation reports
• Contributing to drafting regulatory submissions
• Ensuring compliance with all applicable regulatory guidelines
What experience and education do you need?
You’ll need to have a BS degree with 8+ years of biotechnology and/or pharma industry experience, or an MS degree with 4+ years of biotechnology and/or pharma experience, or a Ph.D. with 1+ years of biotechnology and/or pharma experience.
Candidates should have the following experience:
• Demonstrated knowledge and experience developing potency ELISAs for protein therapeutics, including best practices and data interpretation
• Knowledge and experience transferring, troubleshooting, and validating assays is required
• Functional agility, adaptability, and ability to work in a fast-paced matrix environment
• Experience navigating within a “start-up” biopharmaceutical company
What skills does our ideal candidate have?
As our ideal candidate, you’ll need the follow skills and knowledge:
• Demonstrated analytical and problem solving capabilities
• Capable of interpreting results, formulating conclusions from complex datasets,
• Knowledgeable of global regulatory CMC documents and requirements
• Familiarity with qualification/validation practices and best practices (i.e. GLP, GMP)
• Demonstrated written and verbal communication skills with peers and management
• Demonstrated ability to build and maintain positive and collaborative relationships across functional areas and with management
• Detail oriented, proactive, and self-motivated
• Knowledge and experience developing HPLC- and/or CE-based methods is a plus
• Knowledge and experience with small and large molecules is a plus
If you have the skills, knowledge and experience we are looking for, we’d love to hear from you!
All interested applicants should apply at: Omeros.com, About Omeros, Careers. This will route you to our online applicant tracking system.
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 email@example.com or contact Omeros, asking for Human Resources, at (206) 676-5000.