Sr QC Associate, Quality Control
Omeros is seeking a Sr. Quality Control Associate to join the QC team to support clinical and commercial development of antibody therapeutics. This role 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, support tech transfer, validation, and lifecycle management of analytical methods, and establish internal GMP-compliant best practices.
Good things are happening at Omeros!
Come join our QC Group!
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 injection) 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:
- Reviewing and managing QC data to support GMP manufacturing (in-process testing) as well as release, and stability testing of clinical and commercial drug substance and drug product
- Reviewing data quality and integrity, data trending, and establishing control charts
- Supporting tech transfer, validation, lifecycle management, troubleshooting, and remediation of analytical methods
- Managing material inventories, developing and managing SOPs, and support establishing product specifications for antibody therapeutics
What education, experience, skills, and knowledge do you need?
You’ll need to have a BS or MS degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field with 3+ years of biotechnology and/or pharmaceutical industry experience; for a BS degree+ years of overall related experience is required, for an MS degree 2+ years of overall experience is required.
Candidates should have the following skills, knowledge and experience:
- Technical and practical understanding of chromatographic (SEC, RP, peptide map, CEX, etc.), electrophoretic (CE-SDS, SDS-PAGE, icIEF), impurity (host cell protein ELISA, residual protein A ELISA, etc.), potency (binding, functional), and compendial (pH, osmolality, bioburden, endotoxin, sterility) assays
- Demonstrated capability of reviewing and interpreting data and reports
- Experience overseeing analytical release and stability testing at CROs and CMOs
- Experience developing and maintaining a product quality database for data trending and establishing acceptance criteria and product specifications
- Experience in the management of tech transfer and qualification and/or validation of analytical methods at clinical and commercial stage CROs and CMOs
- Familiarity with FDA/EMA regulations, ICH guidance documents, and compendia (US, EU)
- Knowledge and experience writing Standard Operating Procedures (SOP’s), test methods, and qualification / validation reports
- Familiarity with document change controls and lifecycles
- Ability to ensure compliance with all applicable regulatory guidelines
- 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
Additional skills our ideal candidate will have:
- Experience and proficiency with Waters Empower software
- Experience with testing and release of raw materials and supply chain management
If you have the skills, knowledge and experience we are looking for, we’d love to hear from you!
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 email@example.comOpens a New Window. or contact Omeros, asking for Human Resources, at (206) 676-5000.