Temporary Clinical Supply Specialist II

Location
Seattle
Posted
Oct 19, 2019
Ref
1617
Required Education
Bachelors Degree
Position Type
Full time
Good things are happening at Omeros!

Come join our CMC Omeros Team!

The Clinical Supply Specialist II is responsible for some of the activities as they relate to the support of the Company's Supply Chain for clinical trial materials (CTM). The individual will work with Clinical Operations, QA/RA, and Clinical Data Management to address CTM needs and will work under the supervision of his/her manager to perform the duties to ensure on-time delivery of CTM for various studies. This position will also ensure that all the data related to those efforts are managed appropriately.

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.

What are your job responsibilities?

Your responsibilities in this position will include:

  • Support tactical and day to day clinical supply chain activities with the larger objective in mind of company goals to optimize inventory, minimize costs, and help achieve Clinical Operation's goals
  • Work with Contract Manufacturing Organizations (CMO) relating to clinical supply and drug product, as needed
  • Coordinate activities related to packaging, labeling, shipping, and storage of CTMs on an as-needed basis
  • Maintain all aspects of record keeping and data management, per assigned activities - offline and online
  • Perform other duties and responsibilities as required
  • Prefer a science-based bachelor's degree (or equivalent) with a minimum of 2-3 years related experience with the clinical supply/clinical operations
  • Knowledge of GXP and global regulatory requirements preferred, but not required
  • Expert knowledge of MS Office, Excel, and Project is required
  • Excellent communication skills (written and verbal) and demonstrated initiative and integrity are required
  • Excellent interpersonal and management skills and the ability build and maintain positive relationships with management, peers, and external contract organizations are essential
  • Must display exceptional analytical, organizational, and problem-solving skills
  • Attention to detail required.
  • Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates
  • Integrity
  • Must display strong analytical and problem-solving skills.
  • Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 40 lbs
  • May encounter prolonged periods of sitting
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.