Manager, Analytical Development & Quality Control 10/11/2017
JOB DESCRIPTIONAPPLY Omeros has an opportunity for a Manager to join the Analytical Development and Quality Control team who will be responsible for leading and managing internal and external activities involved in analytical method development, troubleshooting, transfer, and validation, product formulation and stability studies, process development , manufacturing, release and stability testing of drug substance and drug products, and supporting investigations for early-stage large and small molecule therapeutics.
Good things are happening at Omeros!
Come join our CMC Group!
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 injection) 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.
Your job responsibilities:
Acting as a representative of the CMC group on project team(s)
Interacting internally with cross-functional representatives and externally with third party contract organizations
Leading and managing activities and relationships between global contract manufacturing (CMO) and testing (CRO) organizations
Leading and managing development, tech transfer, and qualification and/or validation of analytical methods to clinical stage CROs and CMOs
Generating and reviewing method qualification and validation protocols and reports
Overseeing analytical release and stability testing
Reviewing raw data in internal notebooks as well as data and reports from contract organizations
Drafting analytical related regulatory reports and submissions
Assisting in investigations
Monitoring/evaluating compendia changes and implementing to existing procedures
Keeping updated with new FDA/EMA regulations and ICH guidelines
Writing Standard Operating Procedures (SOP s), standard test methods and qualification/validation reports
Managing CMC document change controls
Ensuring compliance with all applicable regulatory guidelines