Scientist II, Formulation Development

Location
Seattle, WA, United States
Posted
May 25, 2021
Ref
1813
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
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.

Who is Omeros?

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros' proprietary G proteincoupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.

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