Sr. Quality Control Associate, Chromatography/Wet Chemistry

Location
Seattle
Posted
Nov 20, 2020
Ref
1784
Hotbed
BioForest
Required Education
Associate Degree
Position Type
Full time
This position will support clinical and commercial development and analyses of monoclonal antibodies. It requires having a good understanding of the functional and structural characteristics of monoclonal antibodies and several years of hands-on experience performing analytical chemistry, HPLC and capillary electrophoresis assays on antibodies.

The position requires management of QC activities and testing at various contract organizations, where he/she will play a key role ensuring QC testing and test results for chromatographic, electrophoretic and other needed data is 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, validation, troubleshooting, investigations and lifecycle management of analytical methods, as well as establishing internal best practices. The management of stability programs and small molecule experience is a big plus.

Good things are happening at Omeros!

Come join our Omeros CMC 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:

  • Support in-process, release and stability testing of clinical and commercial drug substance and drug product at contract organizations
  • Review of Chromatographic, electrophoretic and other QC test data 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 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 assigned
  • BS or MS degree in Biochemistry, Analytical Chemistry or 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
  • Small molecule experience is also a plus
  • Working knowledge of monoclonal antibodies and large molecule biologics
  • Hands on HPLC experience (affinity, CIEX, SEC, RP)
  • Hands on Capillary Electrophoresis (CE) equipment and testing experience (CZE, CE-SDS, cIEF)
  • Spectrophotometric determination of protein concentration
  • Wet chemistry techniques
  • USP, EP, JP Compendia testing (Appearance, pH, Osmolality, Particulate)
  • 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