Assoc Director/Director, Quality Control

Location
Seattle
Posted
Nov 02, 2020
Ref
1779
Discipline
Quality, Quality Control
Hotbed
BioForest
Required Education
Masters Degree/MBA
Position Type
Full time
Omeros is seeking an Associate Director/Director of Quality Control (QC) who will provide strategic leadership in managing a growing team of scientists responsible for QC-related activities and operations. This individual will be responsible for providing scientific leadership, defining QC strategy and determining a roadmap for QC related activities and operations to meet corporate objectives. The scope of this role covers all phases of product development (clinical and commercial) at Omeros for both large and small molecule programs.

Come join Omeros!

Come join our 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 as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system.

The company's drug product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is marketed in the U.S. for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.

Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington's disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.

Primary Responsibilities:

  • Lead Quality Control (QC) activities for clinical and commercial products, including management of in-process and release testing of GMP products
  • Lead and manage QC staff including hiring, developing, evaluating and goal setting
  • Oversee GMP clinical and commercial stability planning, execution, data analysis and data trending in support of product expiry/shelf life determination
  • Oversee Quality Control requirements for compliance with cGMP regulations at external contract manufacturing and testing organizations
  • Oversee product release and stability specification setting and COA generation
  • Oversee and approve release of QC components of GMP manufacturing batch and test records at external contract organizations
  • Develop Quality Control strategy and direction in conjunction with the development of analytical methods and manufacturing processes by the Omeros Technical Development teams
  • Partner with internal and external stakeholders to transfer, qualify and validate analytical methods
  • Establish and maintain quality control standards applicable to the clinical and commercial product phases
  • Author/review relevant sections of regulatory filing reports and submissions
  • Drive continuous improvement projects in collaboration with internal and external stakeholders
  • MS or PhD in Analytical Chemistry or a related scientific field
  • 10+ years Quality Control experience is required, preferably with both small molecules and biologics
  • Strong knowledge of GMPs, ICH guidelines and Quality management systems
  • Experience with technology transfer to third parties
  • Experience with regulatory authority meetings and GMP site inspection
  • Extensive experience with analytical method development and validation
  • Expertise with stability testing, data trending and expiry setting strategy
  • Experience with testing injectable and oral dosage forms preferred
  • Experience in big pharma/biotech; experience in a startup biopharma company is desirable
  • Proficiency in MS Office, Word and Excel; statistical analysis software is desirable
  • Demonstrated ability to build and maintain positive and collaborative relationships with management, peers, subordinates, and externally with third party contract organizations
  • Excellent written and oral communication skills with a proven track record of developing employees
  • Self-motivated and detail-oriented, with the highest integrity
  • Occasionally required to travel overnight
  • Ability to travel 10% of the time
  • Management and supervision of a small team and contractor(s)
  • Responsibilities may include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems
  • Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 40 lbs.
  • May encounter prolonged periods of sitting
  • This position requires working with and near hazardous material
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.