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Scientist I, Analytical Development

Employer
Omeros Corporation
Location
Seattle, WA
Start date
Sep 27, 2022

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Job Details

 

Scientist I, Analytical Development

 

This position will primarily be responsible for the development, transfer, qualification, and validation of potency bioassays in support of clinical development and commercialization of antibody therapeutics.  The Scientist may also contribute to the development, transfer, and qualification / validation of impurity ELISAs and analytical HPLC and/or CE methods to monitor physicochemical quality attributes for both protein and small-molecule therapeutics. The individual will develop and implement methods for characterization, contribute to tech transfer to clinical and commercial stage CROs / CMOs, and provide input to and manage external CROs who may develop and implement methods for characterization, release, and stability testing.

 

 Come join our highly talented CMC Team and help shape the future of Omeros!

 

About Omeros Corporation

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 www.omeros.com.

 

  

Your specific job responsibilities will include:

 

  • Analytical method development, testing, transfer, qualification, and validation in a GLP and/or GMP environment
  • Troubleshoot typical method and equipment challenges
  • Write standard test methods, technical reports summarizing analytical data, and qualification / validation reports
  • Participate in cross-functional teams as a representative of the Analytical Development group
  • Assists in trouble-shooting CMC-related problems from CROs / CMOs
  • Assists in investigations involving data generated internally and by CROs / CMOs
  • Ensures laboratory equipment is calibrated and maintained in proper working order to enable compliance with GLP and/or GMP environments
  • Contribute to drafting regulatory submissions
  • Ensures compliance with all applicable regulatory guidelines

 

Education and Experience needed:

 

  • Demonstrated knowledge and experience developing potency ELISAs for protein therapeutics and interpreting data is required
  • Knowledge and experience transferring, troubleshooting, and validating assays is required
  • Knowledge and experience developing HPLC and/or CE based methods is a plus
  • Small and large molecule experience is desired
  • Demonstrated problem-solving capabilities
  • Knowledgeable in global regulatory CMC documents
  • Familiar with GMPs and qualification / validation practices
  • ≥1 (for Ph.D.) or ≥8 (for B.S.) years of biotechnology and/or pharmaceutical industry experience required
  • BS, MS or Ph.D. in biology, biochemistry, analytical chemistry, or a related field
  • Experience with “start-up” biopharma company desirable
  • Excellent communication, analytical, and organizational skills required 

 

Behavioral Competencies Required: 

 

  • Must have the ability to build and maintain positive and collaborative relationships with management and peers 
  • Excellent written and verbal communication skills required
  • Must display strong analytical and problem-solving skills
  • Attention to detail required

 

 Physical Demands Required:

 

  • Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 40 lbs. 
  • May encounter prolonged periods of sitting
  • This position requires working with and near hazardous material

 

This is an opportunity for you to be a key member of a collaborative group contributing your talent and expertise to a company that has an exciting pipeline. If you have the knowledge, skills 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.

 

 

Company

At Omeros, we are proud of our innovative and cutting-edge science. Our world-class team has achieved scientific advances that no other group has been able to accomplish, delivering wholly new classes of therapeutics to benefit patients. We let science lead the way.

From our foundation of groundbreaking science, we continue to build and advance a deep and diverse pipeline of small-molecule and protein therapeutics. We are not interested in developing “me-too” products; instead, we are focused on tackling challenging diseases and disorders with significant unmet medical needs. The result is an exciting pipeline of first-in-class drugs with new mechanisms of action that target previously untapped receptors and enzymes.

The Omeros team is exceptionally talented, passionate, collaborative and diverse. We hire smart, creative and hard-working people who want to play a meaningful part in building a preeminent biopharmaceutical company. We come from all corners of the globe, bringing unique abilities and experiences together to provide hope to patients and their families.

Find Us
Phone
206.676.5000
Location
201 Elliott Avenue West
Seattle
98119
US
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