Position Description

Sr. Quality Control Associate, Immunoassay/Bioassay
Location CORPORATE - Seattle
# of openings 1
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Sr. Quality Control Associate, Immunoassay/Bioassay

 

 

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? 

 

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 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​

 

 

What education and experience do you need?

 

 

  • 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

 

 

What knowledge, skills and abilities does our ideal candidate have?

 

 

  • 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

 

 

Behavioral Competencies we are seeking: 

 

 

  • 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

 

 

Other things you'll need to know:

 

 

  • 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

 

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