Associate Scientist, Formulation Development

Location
Seattle, WA
Posted
May 16, 2022
Ref
1796
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time

Senior Research Associate, Formulation Development 

 

 

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

 

What are your job responsibilities?

 

  • Conduct formulation development and stability studies to support various phase-appropriate antibody drug candidates
  • Run routine analytical tests such as size exclusion chromatography, sub-visible particle analysis, icIEF, CE-SDS, CEX-HPLC, viscosity, pH, protein concentration, and appearance
  • Assist with IV compatibility, in-use stability and microbial challenge studies to recommend clinical and commercial dosing strategy
  • Contribute to writing technical transfer documents to support the process development and manufacturing of clinical drug substances and drug products
  • Author formulation development and compatibility technical documents for internal use and to support regulatory filings
  • Present work at group, departmental, and cross functional meetings

 

What education and experience do you need?

 

  • BS degree in Life Sciences, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Bioengineering or a related field with 5+ years of experience is required or an MS degree with 2 + years of experience is required
  • Experience with formulation development activities for monoclonal antibodies and novel protein-based molecules, IV admixture compatibility, microbial challenge study, or sterile product development and manufacturing is preferred
  • 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
  • Familiarity with drug product manufacturing and tech transfer support.

 

Behavioral Competencies:

 

  • Collaboration & Teamwork: Demonstrates the ability to relate to employees and management in a cooperative manner that helps others to achieve their best
  • Productivity/Organizing/Planning: Demonstrates ability to meet deadlines, effectively use time, and handle multiple assignments simultaneously
  • Communication Skills: 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 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