Sr. Quality Control Associate, Immunoassay/Bioassay

Location
Seattle
Posted
Dec 22, 2020
Ref
1728
Hotbed
BioForest
Required Education
Associate Degree
Position Type
Full time
This position is for an immunoassay/bioassay QC Senior Associate who will support clinical and commercial development and analyses of monoclonal antibodies. The successful candidate is expected to have a good understanding of the function and structural characteristics of monoclonal antibodies with several years of hands-on experience performing immunoassay and bioassays.

The position requires management of QC activities and testing at various contract organizations, where he/she would play a key role ensuring QC testing and test results for immunoassays (such as ELISAs), bioassays and other needed data are generated promptly and accurately by planning ahead and continuously tracking activities between OMEROS and the contract organization(s).

Other related responsibilities include review and maintenance of data associated with cGMP release and stability testing of drug substance and drug product. Supporting analytical transfer activities, validations, assay troubleshooting, investigations, and lifecycle management of analytical methods, as well as establishing internal best practices.

Prior experience with the management of QC stability programs is a plus.

Good things are happening at Omeros!

Come join our Omeros CMC Team!

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.

What are your job responsibilities?

  • Your responsibilities in this position will include:
  • Support in-process, release and stability testing of clinical and commercial drug substance and drug product lots at outsourced contract organizations
  • Review of bioanalytical, bioassay and other QC test results to support GMP manufacturing and release of drug substance and drug product lots
  • Track QC activities; follow up on deliverables and resolve pending issues
  • Help identify problems and assist with investigations and their resolution
  • Tracking, trending and maintenance of standards, controls and critical reagents; in-house and/or at contract labs
  • Provide internal and external QC support to help establish and monitor assay control trending charts
  • Support setting specifications
  • Write and review protocols and reports
  • Write and revise SOPs
  • Ensure compliance with all applicable regulatory guidelines
  • Other duties as required
  • BS or MS degree in Immunochemistry, Biochemistry, or a related field
  • 8+ years of pharmaceutical industry experience
  • 5+ years in a QC GMP environment with a minimum of 3 years of commercial product testing experience
  • Management of QC stability program is a big plus
  • Working knowledge of monoclonal antibodies and large molecule biologics
  • Experience developing and performing ELISA assays
  • Experience with cell based, cell signal receptor or other types of bio-functional assays
  • Experience with cell culture and aseptic techniques
  • Experience with Deviations and OOS investigations; CAPA and Change Controls
  • Good knowledge of ICH, FDA, EU guidelines and regulations
  • Excellent written and verbal communication skills
  • Energetic, proactive and self-motivated
  • Excellent attention to detail
  • Good listener and communicator
  • Demonstrated problem-solving and multi-tasking abilities
  • Ability to build and maintain positive and collaborative relationships across functional areas, with management, peers and external partners
  • Well organized, detail oriented and deadline driven
  • Self-motivated and adaptable to changing priorities
  • Able to function well in a fast-paced environment and under pressure
  • 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