Manager, Analytical Development & Quality Control
This is an exciting time at Omeros with lots of opportunities for growth!
Come join our CMC Group!
Who is Omeros?
Omeros is a Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system.
Part of its proprietary PharmacoSurgery® platform, the company's first drug product, OMIDRIA® (phenylephrine and ketorolac injection) 1%/0.3%, was broadly launched in the U.S. in April 2015. OMIDRIA is the first and only FDA-approved drug (1) 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 and (2) that contains an NSAID for intraocular use. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has 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 proprietary G protein-coupled receptor, or GPCR, platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development, and a platform used to generate antibodies.
What will your responsibilities be?
Reporting to the Director, Analytical Development & QC, you will be responsible for managing the internal and external activities involved in analytical method development and validation, supporting of product formulation and process development, release and stability testing of drug substance and drug products for both large and small molecule therapeutics. In this role, you will also have responsibility for managing the training, development and task assignment for those that report to you. You’ll provide input and advice to staff on troubleshooting the analytical challenges encountered by CRO’s we are utilizing that may be developing the methods and testing products for us at clinical and/or commercial stages. Specifically, your responsibilities will include:
• Generating Specifications and Certificate of Analysis
• Reviewing raw data in internal notebooks as well as data and reports from contract organizations
• Generating and reviewing method qualification and validation protocols and reports
• 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
• Ensuring laboratory status and equipment is in GMP compliance
• Managing CMC document change controls
• Managing, coaching and developing direct reports
• Assisting in writing analytical-related regulatory reports and submissions
• Ensuring compliance with all applicable regulatory guidelines
• Interacting internally with cross-functional representatives and externally with third party contract organizations
What does our ideal candidate look like?
Our ideal candidate will have extensive experience in GMP lab and quality control and experience in analytical method development and validation, especially for the methods of HPLC, UPLC and LC/MS. Experience with CE-SDS, cIEF and Immuno-Assay will be considered a plus. You’ll bring your practical experience in analytical testing in a cGMP environment and specification generating. Small molecule experience is required; experience with testing injectable and oral dosage forms is preferred. Experience with technology transfer to third parties is desired. You’ll be knowledgeable in and with global regulatory CMC documents (eCTD) and familiar with GMP’s and ICH Guidelines.
To be successful in this role, along with your leadership skills, you will have excellent problem-solving skills, analytical abilities and multi-tasking capabilities as well as effective communication and excellent planning and organizational skills.
What else will you need?
• PhD in Analytical Chemistry or a related field with 5+ years of biotechnology and/or pharmaceutical industry experience, or an MS with 7+ years of industry experience or a BS degree with 9+ years of industry experience or equivalent relevant industry experience.
• Our ideal candidate will have experience in big pharma/biotech and any experience you may have in a “start-
up” biopharma company would be considered a plus.
If you have the skills and experience we are looking for, want to join a growing organization and want to make an impact, we'd love to here from you!
All interested applicants should apply at: Omeros.com, About Omeros, Careers. This will route you to our online applicant tracking system.
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 firstname.lastname@example.org or contact Omeros, asking for Human Resources, at (206) 676-5000.