Principal Scientist, Analytical Development

Location
Seattle, WA
Posted
May 13, 2022
Ref
1945
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time

Principal Scientist, Analytical Development

We are seeking a Principal Scientist, Analytical Development who will support clinical and commercial development of biological therapeutics. This position will involve technical and team leadership both within the Analytical Development group and on cross-functional project teams.

 

 

Good things are happening at Omeros!

Come and be a part of our CMC Team!

 

 

Who is Omeros?

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 .

 

Essential Duties & Responsibilities: 

  • Represent Analytical Development at cross-functional project teams
  • Lead a team aimed at developing and optimizing chromatographic (HPLC, UPLC, LC-MS) and/or electrophoretic (CE-SDS, icIEF) methods
  • Direct product characterization and comparability studies
  • Manage qualification, tech transfer, and validation of analytical methods internally and in partnership with CROs and CMOs
  • Support release and stability testing with external partners
  • Lead technology development initiative aimed at evaluating orthogonal and complimentary technologies to improve capability, efficiency, and throughput within the group

 

Education, Experience, Skills, and Knowledge Required:

  • Requires a Ph.D. (or equivalent) in Biochemistry, Chemistry or a related field with 12 years of biotechnology and/or pharmaceutical industry experience including post doc experience; a BS or MS degree with directly related experience will also be considered
  • Strong understanding of technical principles and data interpretation of chromatographic and/or electrophoretic methods
  • Experience developing, qualifying, and transferring robust HPLC (SEC, reversed-phase, peptide map, CEX, etc.) and/or CE-based (CE-SDS, icIEF) methods
  • Proficient working as a member of collaborative cross-functional teams
  • A track record of successfully managing activities and relationships and meeting timelines within an organization and in collaboration with external partners
  • Familiarity with developing stable formulations and executing stability studies for biologics
  • Familiarity with Regulatory guidance documents (ICH, FDA, USP, etc.) and filings (IND, IMPD, BLA); experience in authoring analytical related CMC sections is a plus

 

Behavioral Competencies Required: 

  • Ability to build and maintain positive relationships with management, peers, subordinates is essential
  • High-performing, detail oriented, proactive, and team-oriented
  • The ability to work well in a dynamic organization
  • Capable of leading and coaching

 

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.