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Scientist II, Formulation Development

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

View more

Discipline
Science/R&D, Biotechnology
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
BioForest

Job Details

Scientist II, Formulations Development

 

Good things are happening at Omeros!

 

Come join our CMC Team!

 

 

This position will be responsible for formulation development of monoclonal antibodies to support preclinical, clinical, and commercial phase of multiple programs. The position has 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.

 

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.

 

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

 

Education, Experience, Skills, and Knowledge Required: 

 

  • Ph.D. degree in Life sciences, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Bioengineering or a related field with 2+ years of experience or MS degree with 5+ years of experience is required.
  • Experience in formulation development of monoclonal antibodies and novel protein-based molecules, IV admixture compatibility, microbial challenge study, or sterile product development and manufacturing is preferred
  • Strong scientific understanding and experience with pharmaceutics, pharmaceutical science, protein chemistry, biophysical/biochemical characterization of proteins, bioanalytical method development.
  • Hands-on experience and trouble-shooting proficiency with column chromatographic (HPLC/UPLC), electrophoretic, and biophysical techniques (such as DLS, CD, FTIR, DSC, AUC, fluorescence, HIAC, MicroFlow Imaging) for protein characterization
  • Demonstrated problem-solving capabilities
  • Familiarity with drug product manufacturing and tech transfer support.
  • Familiarity with global regulatory CMC documents
  • Familiarity with GMPs, manufacturing unit operations, and process validation practices. 

 

Behavioral Competencies Required: 

  • Collaboration & Teamwork: Relates to employees and management in a cooperative manner that helps others to achieve their best
  • Productivity/Organizing/Planning: Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously
  • Communication Skills: The ability to convey both written and verbal information effectively and efficiently
  • Willingness to Acknowledge Areas for Growth: Understands need for growth and is receptive to constructive feedback
  • Detail-Oriented: Follows precise procedures and demonstrates thoroughness in performing job tasks and assignments

 

Physical Demands and Work Environment Required:  

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

 

If you have the experience, skills and knowledge we are seeking, we’d love to hear from you! This is an exciting opportunity for the right person!

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.

Company info
Website
Phone
206.676.5000
Location
201 Elliott Avenue West
Seattle
Washington
98119
US

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