Sr. Quality Control Associate, Biologics

Sr. Quality Control Associate, Biologics

The Omeros Quality Control group is seeking an experienced professional with broad experience in clinical and commercial analytical and quality aspects of pharmaceuticals to help manage large molecule biologics drug substance and drug product testing, stability studies, method transfer, qualification/validation supporting CMC activities. This position will interact routinely with third-party CMO's, contract test labs, Omeros technical operations, and QA and Regulatory Affairs.

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:

• Review and manage QC data to support GMP manufacturing
• Oversee release and stability testing of clinical and commercial drug substance and drug product at CRO's and CMO's
• Technical and practical understanding of the following analytical methodologies: chromatographic (SEC, RP, peptide map, CEX, etc.), electrophoretic (CE-SDS, SDS-PAGE, ieIEF), impurity (host cell protein ELISA, residual protein A ELISA, etc.)potency (bioassays), and compendial (pH, osmolality, bioburden, endotoxin, sterility) assays
• Prior experience with functional bioassays is a plus
• Support tech transfer, method validation, life cycle management, troubleshooting, and remediation of analytical methods at CRO's and CMO's
• Participate in cross-functional meetings to ensure design transfer is completed in a timely and acceptable manner
• Knowledge and experience with elecctronic systems such as eDMS, LIMS, Chromatography data management software (i.e. Waters Empower)
• Tracking, trendin and maintenance of standards, controls and critical reagents: in-house and/or at contract labs
• Review in-process, release and stability testing data of clinical and commercial drug substance and drug product lots at oursourced contract organizations
• Ability to effectively resolve technical investigations using a variety of methods, including but not imited to: HPLC, UV, CE, Bioassay, gel electrophoresis, and compendial testing
• Oversee investigations, deviations, CAPAs, and OOS related to release and stability testing
• Support the review of data quality and integrity, data trending, and establish control charts including developing and maintaining a product quality database
• Develop and manage Standard Operating Procedures (SOPs)
• Support establishing product specifications for antibody therapeutics
• Ensuring compliance with all applicable regulatory guidelines

What education and experience do you need?

• 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

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

• 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

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