Assistant Manager Global Supply Chain
Omeros has a new opportunity for an Assistant Manager, Global Supply Chain. In this role you will be responsible for supporting the Company’s Global Supply Chain for commercial products and specific initiatives/activities for the clinical supply chain. You will oversee procurement, logistics, and end to end supply chain of global commercial products at Omeros while ensuring compliance with all applicable regulatory guidelines for cGMP products. Additionally, you will contribute to the preparation of CMC related regulatory reports and submissions.
Good things are happening at 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 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.
What are your job responsibilities?
Your responsibilities in this position will include:
- Managing global supply chain activities for product portfolio to optimize inventory, minimize cost, and set and achieve customer service goals
- Identifying and assessing suppliers of raw materials and components
- Purchasing raw materials and components for commercial manufacturing operations
- Acting as a key liaison between various internal stakeholders (Finance, Marketing, etc.) on developing a forecast and plan production accordingly with suppliers and Contract Manufacturing Organizations (CMOs)
- Managing end-to-end supply chain activities, Commercial and certain clinical programs
- Participating in business reviews with key CMOs and suppliers
- Overseeing technology transfer to CMOs and third-party vendors
- Performing basic financial analysis
- Identifying supply chain risks and pro-actively take steps to mitigate risks
- Reviewing internal technical documents
- Reviewing, analyzing and organizing analytical data, including HPLC, GC/MS, etc.
- Reviewing, analyzing and organizing manufacturing batch records and associated data
- Assisting in the preparation of regulatory filings
What education, experience, skills and knowledge do you need?
You’ll need to have a BS degree in Science or a related degree with a minimum of 2 – 5 years of experience in a pharma or biotech company managing global contract manufacturing and lab organizations; experience with overseas markets is highly desired.
Additionally, we are seeking the following:
- Experience with interacting with QP’s for global drug product release is a plus
- PMP certification is preferred
- Working knowledge of MS Office and MS Project is required
- A demonstrated ability to present, influence and work effectively in a cross-functional team environment to deliver results
- Demonstrate excellent communication skills, both written and verbal
- Demonstrated initiative
- Familiarity with US and EU regulatory submissions (e.g. IND, NDA, MAA, etc.)
What additional skills and competencies does our ideal candidate have?
- Excellent interpersonal and management skills with the ability to build and maintain positive relationships internally with management, peers, and subordinates, and externally with contract organizations
- A demonstrated ability to build and maintain positive relationships and credibility both internally and externally
- Capable of understanding and interpreting data from development experiments, analytical testing and manufacturing batch records to identify trends and areas for improvement
- Demonstrate proficiency preparing regulatory documents
- Leadership skills
What else do you need to know?
- You will be occasionally required to travel overnight; some international travel may also be required
If you have the experience, skills and knowledge that we are seeking, we’d love to hear from you! This is an exciting opportunity for the right person!
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.