Position Description

Sr. Quality Control Associate
Location CORPORATE - Seattle
# of openings 1
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Sr. Quality Control Associate

 

Good things are happening at Omeros!

Come join our CMC Omeros Team!

 

This position will support clinical and commercial development of antibody therapeutics and will have a key role reviewing and managing QC data associated with release and stability testing of clinical and commercial drug substance and drug product, supporting tech transfer, validation, and lifecycle management of analytical methods, as well as establishing internal best practices.

 

Who is Omeros?

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system.

The company’s drug product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is marketed in the U.S. for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.

Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington’s disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.

 

What are your job responsibilities?

 

  • Review and manage QC data to support GMP manufacturing

 

  • Oversee release and stability testing of clinical and commercial drug substance and drug product at CRO’s and CMO’s

 

  • Oversee investigations, deviations, CAPAs, and OOS related to release and stability testing

 

  • Review data quality and integrity, data trending, and establish control charts including developing and maintaining a product quality database

 

  • Support method transfer, method validation, lifecycle management, troubleshooting, and remediation of analytical methods at CRO’s and CMO’s

 

  • Manage material inventories

 

  • Develop and manage Standard Operating Procedures (SOPs)

 

  • Support establishing product specifications for antibody therapeutics

 

  • Ensuring compliance with all applicable regulatory guidelines

 

What education and experience do you need?

 

  • BS or MS degree in Chemistry, Biochemistry, Analytical Chemistry

 

  • 3+ years of biotechnology and/or pharmaceutical experience; for a BS degree

 

  • 5+ years of overall related experience is required, for an MS degree 2+ years of overall experience is required

 

  • Experience and proficiency with Waters Empower software

 

  • Experience with testing and release of raw materials and supply chain management

 

Behavioral Competencies Required: 

 

  • Demonstrated problem-solving and multi-tasking capabilities

 

  • Ability to build and maintain positive and collaborative relationships across functional areas, with management and with external resources

 

  • Detail oriented, organized, adaptable, proactive and self-motivated

 

Physical Demands Required: 

 

  • May encounter prolonged periods of sitting

 

 

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.

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