Quality Control Associate

Temporary - 6 month assignment

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

Good things are happening at Omeros!

Come join our Omeros Commercial Business & Analytics Team!

Who is Omeros?

True innovation requires the right people, and that's what we have at Omeros - smart, hard-working and creative individuals who collaborate and drive to achieve what has not yet been done. We see strength in diversity - diversity in thought, expertise and experience.

We have taken a similar approach in structuring our company. While many bio-techs pursue a single therapeutic area or scientific platform, we are strategically building a deep and diverse pipeline of first-in-class small-molecule and antibody therapeutics. The strength of our scientific discoveries and exclusive intellectual property positions enable our pipeline programs to target highly promising receptors and enzymes that others have not been able to develop.

Although cutting across a wide and diverse range of disorders and therapeutic indications - some orphan, others large-market and many for which there are no approved treatments - all of our drugs on the market and in development target critical unmet needs to improve the lives of patients in meaningful ways.

What are your job responsibilities?

Your responsibilities in this position will include:

• Review QC data to support GMP manufacturing

• Support release and stability testing of clinical and commercial drug substance and drug product at CRO's and CMO's

• Supporting investigations
  • Deviations
  • CAPAs
  • OOS related to release and stability testing
  • Method transfer
  • Method validation
  • Analytical method lifecycle management
  • Troubleshooting

• With direction,
  • Support establishment of product specifications for antibody therapeutics
  • Ensure compliance with all applicable regulatory guidelines

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

• 2+ years of biotechnology experience; for a BS or MS degree 2+ years of overall related experience is required

• Knowledge of testing and release of drug substance and drug product

• Proficiency with Waters Empower software

• Technical and practical understanding of the following:
  • Chromatographic
    • SEC
    • RP
    • Peptide map
    • CEX
  • Electrophoretic
    • CE-SDS
    • SDS-PAGE
    • icIEF

• Impurities (host cell protein ELISA, residual protein A ELISA, etc.)

• Potency (bioassays)

• Compendial
  • pH
  • osmolality
  • bioburden
  • endotoxin
  • sterility assays

• Demonstrated capabilities of reviewing and interpreting data and reports

• Familiarity with
  • FDA/EMA regulations,
  • ICH guidance documents, and
  • Compendia (US, EU)

• Familiarity with document change controls

• Excellent written and verbal skills required

• May encounter prolonged periods of sitting

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