Associate Director, CMC Team Leader and Program Manager

Good things are happening at Omeros!

Come join our CMC Omeros Team!

This position is responsible for leading and managing early and late-stage biologic CMC programs at Omeros. The leader will provide CMC team leadership and project management to CMC teams at Omeros, spanning clinical through commercial biologic product development.

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?

• Coordinate CMC cross-functional activities between Omeros CMC departments and staff

• Manage and maintain CMC timelines and CMC budget within the Corporation

• Interact with program core teams to ensure alignment of CMC with overall program timelines and strategy

• Manage and monitor scope, milestones, risks, and costs associated with each CMC project

• Create communication and documentation tools, such as project dashboards, team meeting minutes, resource models and timelines

• Identify and highlight CMC project risks and issues

• Provide effective CMC mitigation and escalation strategies for projects to address risks and issues

• Work effectively with multiple external contract organization (CMOs, CROs) at the same time, covering various activities on multiple projects

• MS or Ph.D. in Biochemistry, Biology or equivalent relevant industry experience

• Experience leading CMC Teams, with 10+ years of experience in Large Molecule CMC program management/product development

• Proficiency in MS Office, Word and Excel and project management tools (MS Project) required

• Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines

• Experience with startup biopharma company and/or at least one product launch desirable

• Experience with navigating global regulatory CMC documents

• Demonstrated ability to build and maintain positive and collaborative relationships with management, peers and subordinates and lead cross-functional technical teams

• Excellent interpersonal and strong leadership skills with the ability to influence and liaise in a cross-functional team environment

• Self-motivated and detail-oriented, with the highest integrity

• Responsibilities may include planning, assigning, and directing work at CMOs and resolving problems that arise at CMOs

• May supervise lower level employees

• Intermittent physical activity including bending, reaching, pushing, pulling, or lifting, up to 20 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.